Wound HealPhase 2/3NCT06298110
The Effect of PRP on Wound Healing in High Risk Patients Undergoing Abdominal Hysterectomy
A Phase 2/3 study testing Platelets Rich plasma of the same patient in people with Wound Heal and Abdominal Wound, run by Helwan University.
Trial summary
To evaluate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Wound Heal, Abdominal Wound, PRP
- What is being tested?
- Platelets Rich plasma of the same patient
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2024to 25 Sep 2024
- Phase
- Phase 2/3
- 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
- - Female patients aged >18 years.
- Patients undergoing abdominal hysterectomy.
- Patients with a high risk of wound healing complications, including: obesity, diabetes mellitus, use of corticosteroid medication or smoking.
Who cannot join
- - Patients with hemoglobin (Hb) < 10 g/dL.
- Patients with platelet levels < 110 × 103/uL.
- Patients with coagulation disorders (on anticoagulant).
- Patients with malignancy
Trial locations and contacts
No sites are listed yet.
About this study
To evaluate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy.
Read the detailed description
Hysterectomy is one of the most common lines of surgical treatment of various uterine disorders as it provides definitive relief from the associated burdensome symptoms with an estimated prevalence of 13.1 per 10,000 women. The indications for hysterectomy include uterine leiomyomas (fibroid), dysfunctional uterine bleeding, endometrial adenomyosis, genital prolapse, massive postpartum hemorrhages and uterine cancers. Abdominal hysterectomy is still the most commonly used approach although there have been some preferences for vaginal and laparoscopic approaches.
Abdominal hysterectomy is associated with risk of complications. In high-risk women undergoing abdominal hysterectomy, wound healing can be particularly challenging due to a variety of factors, including poor tissue quality, compromised immune function, and underlying medical conditions.
Wound healing is a complex process that involves a series of events that are critical for the restoration of tissue integrity and function. Platelet-rich plasma (PRP) has emerged as a promising therapeutic option for enhancing wound healing in high risk patients. PRP is a concentrated source of platelets and growth factors derived from the patient's own blood. It has been shown to promote tissue regeneration and repair by stimulating cell proliferation, angiogenesis, and collagen synthesis. PRP has been used successfully in a variety of clinical settings, including orthopedics, dentistry, and dermatology.
PRP which contains concentrated growth factors have been reported to accelerate wound healing by30-40% giving a satisfactory outcome in the treatment of chronic skin and soft tissue lesions by supplying large amounts of growth factors and chemokines. When platelets become activated, they secrete Seven fundamental protein growth factors initiating all wound healing process, including platelet-derived growth factor (PDGF), epidermal growth factor (EGF), transforming growth factor (TGF), vascular endothelial growth factor (VEGF), Fibroblast growth factor (FGF), connective tissue growth factor (CTGF) \& insulin like growth factor 1(ILGF 1), which participate in the acceleration of wound healing process.
A randomized controlled trial conducted by Tehranian et al. (2016) evaluated the use of PRP in high risk women after caesarian section. The study found that patients treated with PRP had significantly faster wound healing and a significant reduction in pain compared to those who received standard care. Similarly, another study by Fanning et al. (2007) investigated the use of PRP in women undergoing gynecologic surgery, there were no apparent adverse effects, and pain was significantly reduced.
In our study, we will investigate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy.
- Conditions
- Wound Heal, Abdominal Wound, PRP
- Being tested
- Platelets Rich plasma of the same patient
- Keywords
- PRP, Abdominal hysterectomy, Wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelets Rich plasma of the same patientBiological
on the morning of surgery, 30 mL of venous blood will be drawn from the patient in anticoagulant-containing PRP tube for preparation of PRP solution. The drawn blood will be centrifuged at 1,200 rpm for 12 minutes to be separated into three layers: an upper layer that contains platelets and white blood cells, an intermediate thin layer (the buffy coat) that is rich in white blood cells, and a bottom layer that contains red blood cells. The upper and intermediate buffy layers will be transferred to an empty sterile tube. The plasma will be centrifuged again at 3,300 rpm for 7 minutes to help with the formation of soft pellets (erythrocytes and platelets) at the bottom of the tube. Pellets are homogenized in the lower third (5 mL) of the plasma to create the PRP. The prepared PRP solution will be transferred within sterile single use syringe (3cm) from the laboratory to the operation room, then applied and spread over the subcutaneous space before skin closure
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | on the morning of surgery, 30 mL of venous blood will be drawn from the patient in anticoagulant-containing PRP tube for preparation of PRP solution. The drawn blood will be centrifuged at 1,200 rpm for 12 minutes to be separated into three layers: an upper layer that contains platelets and white blood cells, an intermediate thin layer (the buffy coat) that is rich in white blood cells, and a bottom layer that contains red blood cells. The upper and intermediate buffy layers will be transferred to an empty sterile tube. The plasma will be centrifuged again at 3,300 rpm for 7 minutes to help with the formation of soft pellets (erythrocytes and platelets) at the bottom of the tube. Pellets are homogenized in the lower third (5 mL) of the plasma to create the PRP. The prepared PRP solution will be transferred within sterile single use syringe (3cm) from the laboratory to the operation room, then applied and spread over the subcutaneous space before skin closure Receives: Biological: Platelets Rich plasma of the same patient |
| Control group | No intervention | the patients received no topical treatment in the subcutaneous tissue or the skin before closure during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in wound healing
REEDA descriptive scale will assess degree of wound healing which formed of 4 points in a categorical score assessing 5 items of healing, redness, edema,ecchymosis, discharge approximation of the wound edges, each item is rated on a scale of 0-3 and total score may range between 0-15. lower scores indicating good healing
Measured: day 1, day 7, and day 30
Secondary outcomes (4)
Vancouver scar scale changes
Vancouver scar scale (VSS) use to detect changes of formation of keloids or hypertrophic scars. It assesses 4 subjective variables: vascularity, height/thickness, pliability, and pigmentation within a possible range of 0-14 for the total score. A lower score indicates better healing.
Measured: day 1, day 7, and day 30
Visual Analog Scale changes
Pain was evaluated by the visual analog scale system (VAS) which assesses changes of pain via a continuous measurement instrument. The score is determined by measuring the distance (mm) between the no pain anchor to the point that the patient marks, providing a range of scores from 0-10. A higher score indicates greater pain intensity
Measured: day 1, day 7, and day 30
Hospital readmission
Need to hospital readmission due to wound complications
Measured: 1 month post-operatively
Infection
Presence of infection after surgery
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start10 Mar 2024 (estimated)
- Primary completion25 Aug 2024 (estimated)
- Study completion25 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Wound HealStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Ahmed Mohammed El sayed, Helwan University
- Investigators
- Shimaa Bilal, Professor, Study chair, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298110
- Sponsor's protocol ID
- PRP in Abdominal hysterectomy
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akca A, Yilmaz G, Koroglu N. Platelet Indices as the Predictor of Antibiotics Response in Surgical Wound Infections Following Total Abdominal Hysterectomy. Sisli Etfal Hastan Tip Bul. 2019 Jun 24;53(2):132-136. doi: 10.14744/SEMB.2019.46693. eCollection 2019.
PubMed 32377071Fanning J, Murrain L, Flora R, Hutchings T, Johnson JM, Fenton BW. Phase I/II prospective trial of autologous platelet tissue graft in gynecologic surgery. J Minim Invasive Gynecol. 2007 Sep-Oct;14(5):633-7. doi: 10.1016/j.jmig.2007.05.014.
PubMed 17848327Gohar MM, Ali RF, Ismail KA, Ismail TA, Nosair NA. Assessment of the effect of platelet rich plasma on the healing of operated sacrococcygeal pilonidal sinus by lay-open technique: a randomized clinical trial. BMC Surg. 2020 Sep 22;20(1):212. doi: 10.1186/s12893-020-00865-x.
PubMed 32962673Madueke-Laveaux OS, Elsharoud A, Al-Hendy A. What We Know about the Long-Term Risks of Hysterectomy for Benign Indication-A Systematic Review. J Clin Med. 2021 Nov 16;10(22):5335. doi: 10.3390/jcm10225335.
PubMed 34830617Moscicka P, Przylipiak A. History of autologous platelet-rich plasma: A short review. J Cosmet Dermatol. 2021 Sep;20(9):2712-2714. doi: 10.1111/jocd.14326. Epub 2021 Jul 14.
PubMed 34214233Rodrigues M, Kosaric N, Bonham CA, Gurtner GC. Wound Healing: A Cellular Perspective. Physiol Rev. 2019 Jan 1;99(1):665-706. doi: 10.1152/physrev.00067.2017.
PubMed 30475656Tehranian A, Esfehani-Mehr B, Pirjani R, Rezaei N, Sadat Heidary S, Sepidarkish M. Application of Autologous Platelet-Rich Plasma (PRP) on Wound Healing After Caesarean Section in High-Risk Patients. Iran Red Crescent Med J. 2016 May 17;18(7):e34449. doi: 10.5812/ircmj.34449. eCollection 2016 Jul.
PubMed 27660723Veevers-Lowe J, Ball SG, Shuttleworth A, Kielty CM. Mesenchymal stem cell migration is regulated by fibronectin through alpha5beta1-integrin-mediated activation of PDGFR-beta and potentiation of growth factor signals. J Cell Sci. 2011 Apr 15;124(Pt 8):1288-300. doi: 10.1242/jcs.076935. Epub 2011 Mar 23.
PubMed 21429937
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of PRP on Wound Healing in High Risk Patients Undergoing Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT06298110
- Acronym / sponsor ID
- PRP in Abdominal hysterectomy
- Conditions
- Wound Heal, Abdominal Wound, PRP
- Keywords
- PRP, Abdominal hysterectomy, Wound healing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (estimated)
- Primary completion
- 25 Aug 2024 (estimated)
- Study completion
- 25 Sep 2024 (estimated)
- First posted
- 7 Mar 2024 (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.
To evaluate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy.
Detailed description
Hysterectomy is one of the most common lines of surgical treatment of various uterine disorders as it provides definitive relief from the associated burdensome symptoms with an estimated prevalence of 13.1 per 10,000 women. The indications for hysterectomy include uterine leiomyomas (fibroid), dysfunctional uterine bleeding, endometrial adenomyosis, genital prolapse, massive postpartum hemorrhages and uterine cancers. Abdominal hysterectomy is still the most commonly used approach although there have been some preferences for vaginal and laparoscopic approaches.
Abdominal hysterectomy is associated with risk of complications. In high-risk women undergoing abdominal hysterectomy, wound healing can be particularly challenging due to a variety of factors, including poor tissue quality, compromised immune function, and underlying medical conditions.
Wound healing is a complex process that involves a series of events that are critical for the restoration of tissue integrity and function. Platelet-rich plasma (PRP) has emerged as a promising therapeutic option for enhancing wound healing in high risk patients. PRP is a concentrated source of platelets and growth factors derived from the patient's own blood. It has been shown to promote tissue regeneration and repair by stimulating cell proliferation, angiogenesis, and collagen synthesis. PRP has been used successfully in a variety of clinical settings, including orthopedics, dentistry, and dermatology.
PRP which contains concentrated growth factors have been reported to accelerate wound healing by30-40% giving a satisfactory outcome in the treatment of chronic skin and soft tissue lesions by supplying large amounts of growth factors and chemokines. When platelets become activated, they secrete Seven fundamental protein growth factors initiating all wound healing process, including platelet-derived growth factor (PDGF), epidermal growth factor (EGF), transforming growth factor (TGF), vascular endothelial growth factor (VEGF), Fibroblast growth factor (FGF), connective tissue growth factor (CTGF) \& insulin like growth factor 1(ILGF 1), which participate in the acceleration of wound healing process.
A randomized controlled trial conducted by Tehranian et al. (2016) evaluated the use of PRP in high risk women after caesarian section. The study found that patients treated with PRP had significantly faster wound healing and a significant reduction in pain compared to those who received standard care. Similarly, another study by Fanning et al. (2007) investigated the use of PRP in women undergoing gynecologic surgery, there were no apparent adverse effects, and pain was significantly reduced.
In our study, we will investigate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Biological: Platelets Rich plasma of the same patienton the morning of surgery, 30 mL of venous blood will be drawn from the patient in anticoagulant-containing PRP tube for preparation of PRP solution. The drawn blood will be centrifuged at 1,200 rpm for 12 minutes to be separated into three layers: an upper layer that contains platelets and white blood cells, an intermediate thin layer (the buffy coat) that is rich in white blood cells, and a bottom layer that contains red blood cells. The upper and intermediate buffy layers will be transferred to an empty sterile tube. The plasma will be centrifuged again at 3,300 rpm for 7 minutes to help with the formation of soft pellets (erythrocytes and platelets) at the bottom of the tube. Pellets are homogenized in the lower third (5 mL) of the plasma to create the PRP. The prepared PRP solution will be transferred within sterile single use syringe (3cm) from the laboratory to the operation room, then applied and spread over the subcutaneous space before skin closure |
| Control group | No intervention | –the patients received no topical treatment in the subcutaneous tissue or the skin before closure during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - Female patients aged >18 years.
- Patients undergoing abdominal hysterectomy.
- Patients with a high risk of wound healing complications, including: obesity, diabetes mellitus, use of corticosteroid medication or smoking.
Key exclusion criteria (4 listed)
- - Patients with hemoglobin (Hb) < 10 g/dL.
- Patients with platelet levels < 110 × 103/uL.
- Patients with coagulation disorders (on anticoagulant).
- Patients with malignancy
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 |
|---|---|---|
| Platelets Rich plasma of the same patienton the morning of surgery, 30 mL of venous blood will be drawn from the patient in anticoagulant-containing PRP tube for preparation of PRP solution. The drawn blood will be centrifuged at 1,200 rpm for 12 minutes to be separated into three layers: an upper layer that contains platelets and white blood cells, an intermediate thin layer (the buffy coat) that is rich in white blood cells, and a bottom layer that contains red blood cells. The upper and intermediate buffy layers will be transferred to an empty sterile tube. The plasma will be centrifuged again at 3,300 rpm for 7 minutes to help with the formation of soft pellets (erythrocytes and platelets) at the bottom of the tube. Pellets are homogenized in the lower third (5 mL) of the plasma to create the PRP. The prepared PRP solution will be transferred within sterile single use syringe (3cm) from the laboratory to the operation room, then applied and spread over the subcutaneous space before skin closure | Biological | PRP group |
Primary outcome
changes in wound healing
Time frame: day 1, day 7, and day 30
REEDA descriptive scale will assess degree of wound healing which formed of 4 points in a categorical score assessing 5 items of healing, redness, edema,ecchymosis, discharge approximation of the wound edges, each item is rated on a scale of 0-3 and total score may range between 0-15. lower scores indicating good healing
4 secondary outcomes
Vancouver scar scale changes
Time frame: day 1, day 7, and day 30
Visual Analog Scale changes
Time frame: day 1, day 7, and day 30
Hospital readmission
Time frame: 1 month post-operatively
Infection
Time frame: Up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 32377071Akca A, Yilmaz G, Koroglu N. Platelet Indices as the Predictor of Antibiotics Response in Surgical Wound Infections Following Total Abdominal Hysterectomy. Sisli Etfal Hastan Tip Bul. 2019 Jun 24;53(2):132-136. doi: 10.14744/SEMB.2019.46693. eCollection 2019.
- Background: PubMed 17848327Fanning J, Murrain L, Flora R, Hutchings T, Johnson JM, Fenton BW. Phase I/II prospective trial of autologous platelet tissue graft in gynecologic surgery. J Minim Invasive Gynecol. 2007 Sep-Oct;14(5):633-7. doi: 10.1016/j.jmig.2007.05.014.
- Background: PubMed 32962673Gohar MM, Ali RF, Ismail KA, Ismail TA, Nosair NA. Assessment of the effect of platelet rich plasma on the healing of operated sacrococcygeal pilonidal sinus by lay-open technique: a randomized clinical trial. BMC Surg. 2020 Sep 22;20(1):212. doi: 10.1186/s12893-020-00865-x.
- Background: PubMed 34830617Madueke-Laveaux OS, Elsharoud A, Al-Hendy A. What We Know about the Long-Term Risks of Hysterectomy for Benign Indication-A Systematic Review. J Clin Med. 2021 Nov 16;10(22):5335. doi: 10.3390/jcm10225335.
- Background: PubMed 34214233Moscicka P, Przylipiak A. History of autologous platelet-rich plasma: A short review. J Cosmet Dermatol. 2021 Sep;20(9):2712-2714. doi: 10.1111/jocd.14326. Epub 2021 Jul 14.
- Background: PubMed 30475656Rodrigues M, Kosaric N, Bonham CA, Gurtner GC. Wound Healing: A Cellular Perspective. Physiol Rev. 2019 Jan 1;99(1):665-706. doi: 10.1152/physrev.00067.2017.
- Background: PubMed 27660723Tehranian A, Esfehani-Mehr B, Pirjani R, Rezaei N, Sadat Heidary S, Sepidarkish M. Application of Autologous Platelet-Rich Plasma (PRP) on Wound Healing After Caesarean Section in High-Risk Patients. Iran Red Crescent Med J. 2016 May 17;18(7):e34449. doi: 10.5812/ircmj.34449. eCollection 2016 Jul.
- Background: PubMed 21429937Veevers-Lowe J, Ball SG, Shuttleworth A, Kielty CM. Mesenchymal stem cell migration is regulated by fibronectin through alpha5beta1-integrin-mediated activation of PDGFR-beta and potentiation of growth factor signals. J Cell Sci. 2011 Apr 15;124(Pt 8):1288-300. doi: 10.1242/jcs.076935. Epub 2011 Mar 23.
- Impact of hysterectomy on uterine cancer incidence rates in EgyptLink provided by the sponsor.
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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.
Shimaa Bilal, Professor study chair
Helwan University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Platelets Rich plasma of the same patient in people with Wound Heal and Abdominal Wound, run by Helwan University.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed El Sayed, M.B.B.Ch (01119228215, ahmed_mohammed_ahmed@med.helwan.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in wound healing (time frame: day 1, day 7, and day 30). 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 NCT06298110, which also lists 8 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 8 Mar 2024.