Cesarean WoundNCT04211597
EGF-loaded Chitosan to Facilitate Healing and Prevent Scar Formation of Cesarean Wound
A study testing Silicone gel and microencapsulated polysaccharide and oligopeptide-1(Me-EGF) 40 mcg & 5 mcg in people with Cesarean Wound and Scar; Previous Cesarean Section, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Cesarean section (CS) is a major surgical intervention that affects women at childbearing age. Scarring from CS potentially causes discomfort and psychological distress. Emerging evidence indicates that epidermal growth factor (EGF) plays crucial roles in wound healing with the potential of minimizing scar formation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Wound, Scar; Previous Cesarean Section, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn
- What is being tested?
- Silicone gel and microencapsulated polysaccharide and oligopeptide-1(Me-EGF) 40 mcg & 5 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Sep 2017to 28 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 or older
- Planned for cesarean delivery with Pfannenstiel-incision
- Had not received any treatment for scars at least one month before enrollment
- Capable of understanding study protocol in order to sign the informed consent voluntarily
Who cannot join
- Currently taking any medication that might affect outcome evaluation of this study, including but not limited to: systemic corticosteroids or immunosuppressants
- Currently undergoing any treatments involving lower abdomen, or planning to have such treatments
- Having active infection involving abdomen at the time of recruitment
- Concomitant severe or poorly-controlled illness (e.g., cardiovascular, renal, hepatic, pulmonary or gastrointestinal disease, malignancy or history of HIV infection)
- With any abdominal tumor
- Undergoing urgent cesarean delivery without proper pre-op standard procedure
- Having known allergy to any of the ingredients in any of the products used in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EGF-loaded Chitosan to Facilitate Epithelial Healing And Prevent Scar Formation of Cesarean Wound
Cesarean section (CS) is a major surgical intervention that affects women at childbearing age. Scarring from CS potentially causes discomfort and psychological distress. Emerging evidence indicates that epidermal growth factor (EGF) plays crucial roles in wound healing with the potential of minimizing scar formation. This study aims to investigate the effect of microencapsulated recombinant human EGF (Me-EGF) in scar prevention. Silicone gel was incorporated as part of the routine scar treatment.
Healthy women scheduled for cesarean delivery will be enrolled and randomized to three groups: (1) no scar treatment, (2) silicone gel only, or (3) silicone gel plus Me-EGF. Vancouver Scar Scale (VSS) will be used for scar assessment at the 6th month and 9th month after CS.
Read the detailed description
Objective:
Cesarean section (CS) is a major surgical intervention that affects women at childbearing age. Scarring from CS is expected but certainly not desirable, potentially causes discomfort and psychological distress. Emerging evidence indicates that epidermal growth factor (EGF) plays crucial roles in wound healing with the potential of minimizing scar formation. This study aims to investigate the effect of microencapsulated recombinant human EGF (Me-EGF) in scar prevention. Silicone gel was incorporated as part of the routine scar treatment.
Materials:
The investigational dressing in this study: the microencapsulated polysaccharide and oligopeptide-1 is provided by Good-Care Biotech, Ltd. (brand NewEpi®: 10 mcg Me-EGF/ml, Taipei, Taiwan). The investigational dressing NewEpi® was formulated in spray solution with a proprietary drug delivery system in which rhEGF was encapsulated in chitosan as nanoparticles.
Silicone-based scar therapy has shown the beneficial effects of improving the appearance of scars. Dermatix® (Dermatix® Ultra, Menarini Asia-Pacific, Taiwan) is a Taiwan-FDA approved topical silicone gel and commercially available. It is transparent, odorless and quick drying. Concerning the applicability over lower abdomen area, silicone gel (Dermatix®) was selected to be part of the routine care in this study.
Study Procedures:
Healthy women scheduled for cesarean delivery were enrolled and randomized to three groups: (1) no scar treatment, (2) silicone gel only, or (3) silicone gel plus Me-EGF. Vancouver Scar Scale (VSS: vascularity, pigmentation, elasticity, and height) was used for scar assessment at the 6th month and 9th month after CS.
Eligibility was determined at the screening visit. Details of the study regarding eligibility, purpose, study procedure, scope of care and potential risks were explained. Upon enrollment, full medical history of the participants was obtained, including history of hypertrophic scar or keloid. Scars from previous injuries or surgical incisions were evaluated and recorded. Each patient was randomized to one of the three treatment arms: Group 1 (receiving no scar treatment), Group 2 (silicone gel only), and Group 3 (silicone gel plus Me-EGF). Enrolled participants underwent Cesarean delivery performed by one of the four obstetricians at the Department of Obstetrics and Gynecology of CGMH, as part of their prenatal care. Other than routine surgical wound care, participants in Group 1 did not receive any treatment pertaining to scar prevention.
The day of Cesarean delivery was recorded as Day 0. For participants in Group 3, on day 0 prior to final dermal closure, 4ml of Me-EGF (containing 40mcg microencapsulated polysaccharide and rhEGF) was sprayed evenly along the incision site, subsequently covered with antibiotic ointment and sterile gauze. Another 0.5 ml (5 mcg of Me-EGF) was sprayed during dressing change on day 1 and day 5 respectively. At each dressing change, the sutured wound was cleaned by sterile normal saline, followed by Me-EGF sprays, and waited for two minutes to allow for absorption, then covered with dry sterile gauze. Each participant in Group 2 and Group3 brought home two tubes of silicone gel when they returned for their follow-up visits on day 14. They were instructed to start applying silicone gel evenly to the wound twice a day for two months.
Study Participants:
This study is approved by the Institutional Review Board at Chang-Gung Memorial Hospital (CGMH, Linkou, Taiwan). All practitioners and research staffs are in compliance with Good Clinical Practice guidelines. A total of 60 females scheduled for cesarean birth will be recruited by their primary obstetricians at the Department of Obstetrics and Gynecology of CGMH. Prior to their enrollment, the study procedures will be explained to obtain written informed consents. The inclusion criteria are: (1) Age of 18 or older; (2) planned for cesarean delivery with Pfannenstiel-incision, which is one common method of performing Caesarian sections today; (3) had not received any treatment for scars at least one month before enrollment; and (4) capable of understanding study protocol in order to sign the informed consent voluntarily.
Patients will be excluded if: (1) currently taking any medication that might affect outcome evaluation of this study, including but not limited to: systemic corticosteroids or immunosuppressants; (2) currently undergoing any treatments involving lower abdomen, or planning to have such treatments; (3) having active infection involving abdomen at the time of recruitment; (4) concomitant severe or poorly-controlled illness (e.g., cardiovascular, renal, hepatic, pulmonary or gastrointestinal disease, malignancy or history of HIV infection); (5) with any abdominal tumor; (6) undergoing urgent cesarean delivery without proper pre-op standard procedure, or (7) having known allergy to any of the ingredients in any of the products used in this study.
Clinical Evaluation and Outcome Measures:
There were a total of four time points at which data were collected and photos taken using the same digital camera with fixed settings: day 0 (completion of suture on Cesarean incision), day 1, day 5 before discharge from the hospital, and at follow-up visits in month 3, month 6, and month 9. After enrollment and before day 0, baseline photos of old Cesarean scars were taken from participants who had prior Cesarean childbirth, in addition to photos of other scars from those who had reported history of hypertrophic scar or keloid. Scars were assessed using Vancouver Scar Scale. The VSS consists of 4 parameters: vascularity (0-3), pigmentation (0-3), elasticity (0-5), and height (0-3). Prior to the study commencement, all personnel involved had received mandatory training on scar assessment and VSS scoring. At month 3, 6, and 9, a nurse practitioner took photos and evaluated the incision scar on each patient with VSS. Photos of each healing wound were taken with a ruler placed adjacent to the scar to measure the height raised above skin level. Subsequently all scores were validated twice by different research staffs by using the photos on record. No significant discrepancies were found. At each follow-up visit, the primary obstetrician also assessed each patient for any side effect or adverse event.
Statistical Analysis:
Clinical data and all scar measurements were recorded on case report forms and entered in Microsoft Excel database, later validated by different research staffs as the final scores. Data were analyzed using jamovi statistical software (Version 0.9). Means and standard deviations were presented for interval variables of baseline characteristics. Categorical data at baseline were presented in frequency and analyzed with Chi-Square tests. Nonparametric Kruskal-Wallis tests were performed on VSS scores for between group comparisons. A p-value < 0.05 was considered statistically significant.
- Conditions
- Cesarean Wound, Scar; Previous Cesarean Section, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn
- Being tested
- Control, Silicone gel, microencapsulated polysaccharide and oligopeptide-1(Me-EGF) 40 mcg & 5 mcg
- Medical subject headings
- Cicatrix, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
No scar prevention or treatment.
Silicone gelOther
Dermatix® (Dermatix® Ultra, Menarini Asia-Pacific, Taiwan FDA approved)
microencapsulated polysaccharide and oligopeptide-1(Me-EGF) 40 mcg & 5 mcgOther
4ml (40 mcg) of Me-EGF spray will be given by the operating physician prior to wound closure, followed by daily application of 5 mcg until day +5 after delivery. Starting from day +14, participants will receive FDA approved Silicone gel to be applied to the Cesarean wound twice a day for two months. Participants also receive routine post-partum care as usual.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Control | Sham comparator | Participants receive no scar prevention and treatment for Cesarean wounds. Receives: Other: Control |
| Group 2: Silicone gel | Active comparator | Each participant in Group 2 brought home two tubes of silicone gel when they returned for their follow-up visits on day 14. They were instructed to start applying silicone gel evenly to the wound twice a day for two months. Receives: Other: Silicone gel |
| Group 3: Silicone gel plus Me-EGF | Experimental | 1. The day of Cesarean delivery was recorded as Day 0. For participants in Group 3, on day 0 prior to final dermal closure, 4ml of Me-EGF (containing 40mcg microencapsulated polysaccharide and rhEGF) was sprayed evenly along the incision site, subsequently covered with antibiotic ointment and sterile gauze. Another 0.5 ml (5 mcg of Me-EGF) was sprayed during dressing change on day 1 and day 5 respectively. At each dressing change, the sutured wound was cleaned by sterile normal saline, followed by Me-EGF sprays, and waited for two minutes to allow for absorption, then covered with dry sterile gauze.
2. Each participant in Group 3 brought home two tubes of silicone gel when they returned for their follow-up visits on day 14. They were instructed to start applying silicone gel evenly to the wound twice a day for two months. Receives: Other: Silicone gel; Other: microencapsulated polysaccharide and oligopeptide-1(Me-EGF) 40 mcg & 5 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascularity
Vascularity is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment.
0: Normal; 1: Pink; 2: Red; 3: Purple
Measured: Evaluation of Vascularity is done at: month 3+ follow-up visit.
Pigmentation
Vascularity is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment.
0: Normal; 1: Hypo-pigmentation; 2: Mixed-pigmentation; 3: Hyper-pigmentation
Measured: Evaluation of Pigmentation is done at: month 3+ follow-up visit.
Pliability
Pliability is one the the four subscales in Vancouver Scar Scale (VSS). Score range: 0-5. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment.
0: Normal; 1: Supple; 2: Yielding; 3: Firm; 4: Banding; 5: Contracture
Measured: Evaluation of Pliability is done at: month 3+ follow-up visit.
Height
Height of the scar is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment.
0: flat; 1: 0-2mm; 2: 2-5mm; 3: > 5mm
Measured: Evaluation of Height is done at: month 3+ follow-up visit.
Vascularity
Vascularity is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment.
0: Normal; 1: Pink; 2: Red; 3: Purple
Measured: Evaluation of Vascularity is done at: month 6+ follow-up visit.
Pigmentation
Vascularity is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment.
0: Normal; 1: Hypo-pigmentation; 2: Mixed-pigmentation; 3: Hyper-pigmentation
Measured: Evaluation of Pigmentation is done at: month 6+ follow-up visit.
Pliability
Pliability is one the the four subscales in Vancouver Scar Scale (VSS). Score range: 0-5. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment.
0: Normal; 1: Supple; 2: Yielding; 3: Firm; 4: Banding; 5: Contracture
Measured: Evaluation of Pliability is done at: month 6+ follow-up visit.
Height
Height of the scar is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment.
0: flat; 1: 0-2mm; 2: 2-5mm; 3: > 5mm
Measured: Evaluation of Height is done at: month 6+ follow-up visit.
Vascularity
Vascularity is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment.
0: Normal; 1: Pink; 2: Red; 3: Purple
Measured: Evaluation of Vascularity is done at: month 9+ follow-up visit.
Pigmentation
Vascularity is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment.
0: Normal; 1: Hypo-pigmentation; 2: Mixed-pigmentation; 3: Hyper-pigmentation
Measured: Evaluation of Pigmentation is done at: month 9+ follow-up visit.
Pliability
Pliability is one the the four subscales in Vancouver Scar Scale (VSS). Score range: 0-5. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment.
0: Normal; 1: Supple; 2: Yielding; 3: Firm; 4: Banding; 5: Contracture
Measured: Evaluation of Pliability is done at: month 9+ follow-up visit.
Height
Height of the scar is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment.
0: flat; 1: 0-2mm; 2: 2-5mm; 3: > 5mm
Measured: Evaluation of Height is done at: month 9+ follow-up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start5 Sep 2017
- Primary completion20 Apr 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Cesarean WoundStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Upon enrollment, full medical history of the participants was obtained, including history of hypertrophic scar or keloid. Scars from previous injuries or surgical incisions were evaluated and recorded. Each patient was randomized to one of the three treatment arms: Group 1 (receiving no scar treatment), Group 2 (silicone gel only), and Group 3 (silicone gel plus Me-EGF).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TING-CHANG CHANG, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211597
- Sponsor's protocol ID
- 201601310A3
- Status last verified
- Dec 2019
- First submitted
- 20 Dec 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
PubMed 26849801Kirsner RS, Eaglstein WH. The wound healing process. Dermatol Clin. 1993 Oct;11(4):629-40.
PubMed 8222347O'Kane S, Ferguson MW. Transforming growth factor beta s and wound healing. Int J Biochem Cell Biol. 1997 Jan;29(1):63-78. doi: 10.1016/s1357-2725(96)00120-3.
PubMed 9076942Shah M, Foreman DM, Ferguson MW. Neutralisation of TGF-beta 1 and TGF-beta 2 or exogenous addition of TGF-beta 3 to cutaneous rat wounds reduces scarring. J Cell Sci. 1995 Mar;108 ( Pt 3):985-1002. doi: 10.1242/jcs.108.3.985.
PubMed 7542672Peled ZM, Rhee SJ, Hsu M, Chang J, Krummel TM, Longaker MT. The ontogeny of scarless healing II: EGF and PDGF-B gene expression in fetal rat skin and fibroblasts as a function of gestational age. Ann Plast Surg. 2001 Oct;47(4):417-24. doi: 10.1097/00000637-200110000-00010.
PubMed 11601578Satici A, Guzey M, Dogan Z, Kilic A. Relationship between Tear TNF-alpha, TGF-beta1, and EGF levels and severity of conjunctival cicatrization in patients with inactive trachoma. Ophthalmic Res. 2003 Nov-Dec;35(6):301-5. doi: 10.1159/000074067.
PubMed 14688418Kim YS, Lew DH, Tark KC, Rah DK, Hong JP. Effect of recombinant human epidermal growth factor against cutaneous scar formation in murine full-thickness wound healing. J Korean Med Sci. 2010 Apr;25(4):589-96. doi: 10.3346/jkms.2010.25.4.589. Epub 2010 Mar 19.
PubMed 20358003Ferguson MW, Duncan J, Bond J, Bush J, Durani P, So K, Taylor L, Chantrey J, Mason T, James G, Laverty H, Occleston NL, Sattar A, Ludlow A, O'Kane S. Prophylactic administration of avotermin for improvement of skin scarring: three double-blind, placebo-controlled, phase I/II studies. Lancet. 2009 Apr 11;373(9671):1264-74. doi: 10.1016/S0140-6736(09)60322-6.
PubMed 19362676Repertinger SK, Campagnaro E, Fuhrman J, El-Abaseri T, Yuspa SH, Hansen LA. EGFR enhances early healing after cutaneous incisional wounding. J Invest Dermatol. 2004 Nov;123(5):982-9. doi: 10.1111/j.0022-202X.2004.23478.x.
PubMed 15482488Brown GL, Curtsinger LJ, White M, Mitchell RO, Pietsch J, Nordquist R, von Fraunhofer A, Schultz GS. Acceleration of tensile strength of incisions treated with EGF and TGF-beta. Ann Surg. 1988 Dec;208(6):788-94. doi: 10.1097/00000658-198812000-00019.
PubMed 3264140Shin JU, Kang SW, Jeong JJ, Nam KH, Chung WY, Lee JH. Effect of recombinant human epidermal growth factor on cutaneous scar quality in thyroidectomy patients. J Dermatolog Treat. 2015 Apr;26(2):159-64. doi: 10.3109/09546634.2014.906034. Epub 2014 Apr 8.
PubMed 24708156Lee DW, Lim C, Israelachvili JN, Hwang DS. Strong adhesion and cohesion of chitosan in aqueous solutions. Langmuir. 2013 Nov 19;29(46):14222-9. doi: 10.1021/la403124u. Epub 2013 Nov 6.
PubMed 24138057Lim C, Lee DW, Israelachvili JN, Jho Y, Hwang DS. Contact time- and pH-dependent adhesion and cohesion of low molecular weight chitosan coated surfaces. Carbohydr Polym. 2015 Mar 6;117:887-894. doi: 10.1016/j.carbpol.2014.10.033. Epub 2014 Nov 5.
PubMed 25498713Mao S, Sun W, Kissel T. Chitosan-based formulations for delivery of DNA and siRNA. Adv Drug Deliv Rev. 2010 Jan 31;62(1):12-27. doi: 10.1016/j.addr.2009.08.004. Epub 2009 Sep 29.
PubMed 19796660Chan KY, Lau CL, Adeeb SM, Somasundaram S, Nasir-Zahari M. A randomized, placebo-controlled, double-blind, prospective clinical trial of silicone gel in prevention of hypertrophic scar development in median sternotomy wound. Plast Reconstr Surg. 2005 Sep 15;116(4):1013-20; discussion 1021-2. doi: 10.1097/01.prs.0000178397.05852.ce.
PubMed 16163087
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EGF-loaded Chitosan to Facilitate Epithelial Healing And Prevent Scar Formation of Cesarean Wound
- ClinicalTrials.gov ID
- NCT04211597
- Acronym / sponsor ID
- 201601310A3
- Conditions
- Cesarean Wound, Scar; Previous Cesarean Section, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cesarean section (CS) is a major surgical intervention that affects women at childbearing age. Scarring from CS potentially causes discomfort and psychological distress. Emerging evidence indicates that epidermal growth factor (EGF) plays crucial roles in wound healing with the potential of minimizing scar formation. This study aims to investigate the effect of microencapsulated recombinant human EGF (Me-EGF) in scar prevention. Silicone gel was incorporated as part of the routine scar treatment.
Healthy women scheduled for cesarean delivery will be enrolled and randomized to three groups: (1) no scar treatment, (2) silicone gel only, or (3) silicone gel plus Me-EGF. Vancouver Scar Scale (VSS) will be used for scar assessment at the 6th month and 9th month after CS.
Detailed description
Objective:
Cesarean section (CS) is a major surgical intervention that affects women at childbearing age. Scarring from CS is expected but certainly not desirable, potentially causes discomfort and psychological distress. Emerging evidence indicates that epidermal growth factor (EGF) plays crucial roles in wound healing with the potential of minimizing scar formation. This study aims to investigate the effect of microencapsulated recombinant human EGF (Me-EGF) in scar prevention. Silicone gel was incorporated as part of the routine scar treatment.
Materials:
The investigational dressing in this study: the microencapsulated polysaccharide and oligopeptide-1 is provided by Good-Care Biotech, Ltd. (brand NewEpi®: 10 mcg Me-EGF/ml, Taipei, Taiwan). The investigational dressing NewEpi® was formulated in spray solution with a proprietary drug delivery system in which rhEGF was encapsulated in chitosan as nanoparticles.
Silicone-based scar therapy has shown the beneficial effects of improving the appearance of scars. Dermatix® (Dermatix® Ultra, Menarini Asia-Pacific, Taiwan) is a Taiwan-FDA approved topical silicone gel and commercially available. It is transparent, odorless and quick drying. Concerning the applicability over lower abdomen area, silicone gel (Dermatix®) was selected to be part of the routine care in this study.
Study Procedures:
Healthy women scheduled for cesarean delivery were enrolled and randomized to three groups: (1) no scar treatment, (2) silicone gel only, or (3) silicone gel plus Me-EGF. Vancouver Scar Scale (VSS: vascularity, pigmentation, elasticity, and height) was used for scar assessment at the 6th month and 9th month after CS.
Eligibility was determined at the screening visit. Details of the study regarding eligibility, purpose, study procedure, scope of care and potential risks were explained. Upon enrollment, full medical history of the participants was obtained, including history of hypertrophic scar or keloid. Scars from previous injuries or surgical incisions were evaluated and recorded. Each patient was randomized to one of the three treatment arms: Group 1 (receiving no scar treatment), Group 2 (silicone gel only), and Group 3 (silicone gel plus Me-EGF). Enrolled participants underwent Cesarean delivery performed by one of the four obstetricians at the Department of Obstetrics and Gynecology of CGMH, as part of their prenatal care. Other than routine surgical wound care, participants in Group 1 did not receive any treatment pertaining to scar prevention.
The day of Cesarean delivery was recorded as Day 0. For participants in Group 3, on day 0 prior to final dermal closure, 4ml of Me-EGF (containing 40mcg microencapsulated polysaccharide and rhEGF) was sprayed evenly along the incision site, subsequently covered with antibiotic ointment and sterile gauze. Another 0.5 ml (5 mcg of Me-EGF) was sprayed during dressing change on day 1 and day 5 respectively. At each dressing change, the sutured wound was cleaned by sterile normal saline, followed by Me-EGF sprays, and waited for two minutes to allow for absorption, then covered with dry sterile gauze. Each participant in Group 2 and Group3 brought home two tubes of silicone gel when they returned for their follow-up visits on day 14. They were instructed to start applying silicone gel evenly to the wound twice a day for two months.
Study Participants:
This study is approved by the Institutional Review Board at Chang-Gung Memorial Hospital (CGMH, Linkou, Taiwan). All practitioners and research staffs are in compliance with Good Clinical Practice guidelines. A total of 60 females scheduled for cesarean birth will be recruited by their primary obstetricians at the Department of Obstetrics and Gynecology of CGMH. Prior to their enrollment, the study procedures will be explained to obtain written informed consents. The inclusion criteria are: (1) Age of 18 or older; (2) planned for cesarean delivery with Pfannenstiel-incision, which is one common method of performing Caesarian sections today; (3) had not received any treatment for scars at least one month before enrollment; and (4) capable of understanding study protocol in order to sign the informed consent voluntarily.
Patients will be excluded if: (1) currently taking any medication that might affect outcome evaluation of this study, including but not limited to: systemic corticosteroids or immunosuppressants; (2) currently undergoing any treatments involving lower abdomen, or planning to have such treatments; (3) having active infection involving abdomen at the time of recruitment; (4) concomitant severe or poorly-controlled illness (e.g., cardiovascular, renal, hepatic, pulmonary or gastrointestinal disease, malignancy or history of HIV infection); (5) with any abdominal tumor; (6) undergoing urgent cesarean delivery without proper pre-op standard procedure, or (7) having known allergy to any of the ingredients in any of the products used in this study.
Clinical Evaluation and Outcome Measures:
There were a total of four time points at which data were collected and photos taken using the same digital camera with fixed settings: day 0 (completion of suture on Cesarean incision), day 1, day 5 before discharge from the hospital, and at follow-up visits in month 3, month 6, and month 9. After enrollment and before day 0, baseline photos of old Cesarean scars were taken from participants who had prior Cesarean childbirth, in addition to photos of other scars from those who had reported history of hypertrophic scar or keloid. Scars were assessed using Vancouver Scar Scale. The VSS consists of 4 parameters: vascularity (0-3), pigmentation (0-3), elasticity (0-5), and height (0-3). Prior to the study commencement, all personnel involved had received mandatory training on scar assessment and VSS scoring. At month 3, 6, and 9, a nurse practitioner took photos and evaluated the incision scar on each patient with VSS. Photos of each healing wound were taken with a ruler placed adjacent to the scar to measure the height raised above skin level. Subsequently all scores were validated twice by different research staffs by using the photos on record. No significant discrepancies were found. At each follow-up visit, the primary obstetrician also assessed each patient for any side effect or adverse event.
Statistical Analysis:
Clinical data and all scar measurements were recorded on case report forms and entered in Microsoft Excel database, later validated by different research staffs as the final scores. Data were analyzed using jamovi statistical software (Version 0.9). Means and standard deviations were presented for interval variables of baseline characteristics. Categorical data at baseline were presented in frequency and analyzed with Chi-Square tests. Nonparametric Kruskal-Wallis tests were performed on VSS scores for between group comparisons. A p-value < 0.05 was considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Upon enrollment, full medical history of the participants was obtained, including history of hypertrophic scar or keloid. Scars from previous injuries or surgical incisions were evaluated and recorded. Each patient was randomized to one of the three treatment arms: Group 1 (receiving no scar treatment), Group 2 (silicone gel only), and Group 3 (silicone gel plus Me-EGF).
| Arm | Type | Receives |
|---|---|---|
| Group 1: Control | Sham comparator | Other: ControlParticipants receive no scar prevention and treatment for Cesarean wounds. |
| Group 2: Silicone gel | Active comparator | Other: Silicone gelEach participant in Group 2 brought home two tubes of silicone gel when they returned for their follow-up visits on day 14. They were instructed to start applying silicone gel evenly to the wound twice a day for two months. |
| Group 3: Silicone gel plus Me-EGF | Experimental | Other: Silicone gel, Other: microencapsulated polysaccharide and oligopeptide-1(Me-EGF) 40 mcg & 5 mcg1. The day of Cesarean delivery was recorded as Day 0. For participants in Group 3, on day 0 prior to final dermal closure, 4ml of Me-EGF (containing 40mcg microencapsulated polysaccharide and rhEGF) was sprayed evenly along the incision site, subsequently covered with antibiotic ointment and sterile gauze. Another 0.5 ml (5 mcg of Me-EGF) was sprayed during dressing change on day 1 and day 5 respectively. At each dressing change, the sutured wound was cleaned by sterile normal saline, followed by Me-EGF sprays, and waited for two minutes to allow for absorption, then covered with dry sterile gauze. 2. Each participant in Group 3 brought home two tubes of silicone gel when they returned for their follow-up visits on day 14. They were instructed to start applying silicone gel evenly to the wound twice a day for two months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 18 or older
- Planned for cesarean delivery with Pfannenstiel-incision
- Had not received any treatment for scars at least one month before enrollment
- Capable of understanding study protocol in order to sign the informed consent voluntarily
Key exclusion criteria (7 listed)
- Currently taking any medication that might affect outcome evaluation of this study, including but not limited to: systemic corticosteroids or immunosuppressants
- Currently undergoing any treatments involving lower abdomen, or planning to have such treatments
- Having active infection involving abdomen at the time of recruitment
- Concomitant severe or poorly-controlled illness (e.g., cardiovascular, renal, hepatic, pulmonary or gastrointestinal disease, malignancy or history of HIV infection)
- With any abdominal tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlNo scar prevention or treatment. | Other | Group 1: Control |
| Silicone gelDermatix® (Dermatix® Ultra, Menarini Asia-Pacific, Taiwan FDA approved) | Other | Group 2: Silicone gel, Group 3: Silicone gel plus Me-EGF |
| microencapsulated polysaccharide and oligopeptide-1(Me-EGF) 40 mcg & 5 mcg4ml (40 mcg) of Me-EGF spray will be given by the operating physician prior to wound closure, followed by daily application of 5 mcg until day +5 after delivery. Starting from day +14, participants will receive FDA approved Silicone gel to be applied to the Cesarean wound twice a day for two months. Participants also receive routine post-partum care as usual. | Other | Group 3: Silicone gel plus Me-EGF |
Primary outcome
Vascularity
Time frame: Evaluation of Vascularity is done at: month 3+ follow-up visit.
Vascularity is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment. 0: Normal; 1: Pink; 2: Red; 3: Purple
Pigmentation
Time frame: Evaluation of Pigmentation is done at: month 3+ follow-up visit.
Vascularity is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment. 0: Normal; 1: Hypo-pigmentation; 2: Mixed-pigmentation; 3: Hyper-pigmentation
Pliability
Time frame: Evaluation of Pliability is done at: month 3+ follow-up visit.
Pliability is one the the four subscales in Vancouver Scar Scale (VSS). Score range: 0-5. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment. 0: Normal; 1: Supple; 2: Yielding; 3: Firm; 4: Banding; 5: Contracture
Height
Time frame: Evaluation of Height is done at: month 3+ follow-up visit.
Height of the scar is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment. 0: flat; 1: 0-2mm; 2: 2-5mm; 3: > 5mm
Vascularity
Time frame: Evaluation of Vascularity is done at: month 6+ follow-up visit.
Vascularity is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment. 0: Normal; 1: Pink; 2: Red; 3: Purple
Pigmentation
Time frame: Evaluation of Pigmentation is done at: month 6+ follow-up visit.
Vascularity is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment. 0: Normal; 1: Hypo-pigmentation; 2: Mixed-pigmentation; 3: Hyper-pigmentation
Pliability
Time frame: Evaluation of Pliability is done at: month 6+ follow-up visit.
Pliability is one the the four subscales in Vancouver Scar Scale (VSS). Score range: 0-5. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment. 0: Normal; 1: Supple; 2: Yielding; 3: Firm; 4: Banding; 5: Contracture
Height
Time frame: Evaluation of Height is done at: month 6+ follow-up visit.
Height of the scar is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment. 0: flat; 1: 0-2mm; 2: 2-5mm; 3: > 5mm
Vascularity
Time frame: Evaluation of Vascularity is done at: month 9+ follow-up visit.
Vascularity is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment. 0: Normal; 1: Pink; 2: Red; 3: Purple
Pigmentation
Time frame: Evaluation of Pigmentation is done at: month 9+ follow-up visit.
Vascularity is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment. 0: Normal; 1: Hypo-pigmentation; 2: Mixed-pigmentation; 3: Hyper-pigmentation
Pliability
Time frame: Evaluation of Pliability is done at: month 9+ follow-up visit.
Pliability is one the the four subscales in Vancouver Scar Scale (VSS). Score range: 0-5. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment. 0: Normal; 1: Supple; 2: Yielding; 3: Firm; 4: Banding; 5: Contracture
Height
Time frame: Evaluation of Height is done at: month 9+ follow-up visit.
Height of the scar is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment. 0: flat; 1: 0-2mm; 2: 2-5mm; 3: > 5mm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Background: PubMed 26849801Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
- Background: PubMed 8222347Kirsner RS, Eaglstein WH. The wound healing process. Dermatol Clin. 1993 Oct;11(4):629-40.
- Background: PubMed 9076942O'Kane S, Ferguson MW. Transforming growth factor beta s and wound healing. Int J Biochem Cell Biol. 1997 Jan;29(1):63-78. doi: 10.1016/s1357-2725(96)00120-3.
- Background: PubMed 7542672Shah M, Foreman DM, Ferguson MW. Neutralisation of TGF-beta 1 and TGF-beta 2 or exogenous addition of TGF-beta 3 to cutaneous rat wounds reduces scarring. J Cell Sci. 1995 Mar;108 ( Pt 3):985-1002. doi: 10.1242/jcs.108.3.985.
- Background: PubMed 11601578Peled ZM, Rhee SJ, Hsu M, Chang J, Krummel TM, Longaker MT. The ontogeny of scarless healing II: EGF and PDGF-B gene expression in fetal rat skin and fibroblasts as a function of gestational age. Ann Plast Surg. 2001 Oct;47(4):417-24. doi: 10.1097/00000637-200110000-00010.
- Background: PubMed 14688418Satici A, Guzey M, Dogan Z, Kilic A. Relationship between Tear TNF-alpha, TGF-beta1, and EGF levels and severity of conjunctival cicatrization in patients with inactive trachoma. Ophthalmic Res. 2003 Nov-Dec;35(6):301-5. doi: 10.1159/000074067.
- Background: PubMed 20358003Kim YS, Lew DH, Tark KC, Rah DK, Hong JP. Effect of recombinant human epidermal growth factor against cutaneous scar formation in murine full-thickness wound healing. J Korean Med Sci. 2010 Apr;25(4):589-96. doi: 10.3346/jkms.2010.25.4.589. Epub 2010 Mar 19.
- Background: PubMed 19362676Ferguson MW, Duncan J, Bond J, Bush J, Durani P, So K, Taylor L, Chantrey J, Mason T, James G, Laverty H, Occleston NL, Sattar A, Ludlow A, O'Kane S. Prophylactic administration of avotermin for improvement of skin scarring: three double-blind, placebo-controlled, phase I/II studies. Lancet. 2009 Apr 11;373(9671):1264-74. doi: 10.1016/S0140-6736(09)60322-6.
- Background: PubMed 15482488Repertinger SK, Campagnaro E, Fuhrman J, El-Abaseri T, Yuspa SH, Hansen LA. EGFR enhances early healing after cutaneous incisional wounding. J Invest Dermatol. 2004 Nov;123(5):982-9. doi: 10.1111/j.0022-202X.2004.23478.x.
- Background: PubMed 3264140Brown GL, Curtsinger LJ, White M, Mitchell RO, Pietsch J, Nordquist R, von Fraunhofer A, Schultz GS. Acceleration of tensile strength of incisions treated with EGF and TGF-beta. Ann Surg. 1988 Dec;208(6):788-94. doi: 10.1097/00000658-198812000-00019.
- Background: PubMed 24708156Shin JU, Kang SW, Jeong JJ, Nam KH, Chung WY, Lee JH. Effect of recombinant human epidermal growth factor on cutaneous scar quality in thyroidectomy patients. J Dermatolog Treat. 2015 Apr;26(2):159-64. doi: 10.3109/09546634.2014.906034. Epub 2014 Apr 8.
- Background: PubMed 24138057Lee DW, Lim C, Israelachvili JN, Hwang DS. Strong adhesion and cohesion of chitosan in aqueous solutions. Langmuir. 2013 Nov 19;29(46):14222-9. doi: 10.1021/la403124u. Epub 2013 Nov 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone gel and microencapsulated polysaccharide and oligopeptide-1(Me-EGF) 40 mcg & 5 mcg in people with Cesarean Wound and Scar; Previous Cesarean Section, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascularity (time frame: Evaluation of Vascularity is done at: month 3+ follow-up visit.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04211597, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.