BurnsPhase 1EMD-SCZ-SGSNCT02737943
Effect of Mebo Dressing Versus Standard Care on Managing Donor and Recipient Sites of Split-thickness Skin Graft
A Phase 1 study testing Moist Exposed Burn Ointment (MEBO) and Zagazig in people with Burns, run by Zagazig University at 1 site in Egypt.
Trial summary
40 Egyptian Cases with split-thickness skin graft receiving treatment at Zagazig University Hospitals. Study Duration:6 Months .Description of Agent or Moist Exposed Burn Ointment (MEBO). Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- Burns
- What is being tested?
- Moist Exposed Burn Ointment (MEBO) and Zagazig
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to Jul 2019
- Phase
- Phase 1
- 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 2 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who will be managed using split-thickness skin graft.
- Donor skin grafts are harvested from a site in the thigh (a minimum of 5 x 5-cm total area).
- Intention for treatment at Zagazig University.
- Age between 2 \& 60 years.
- An approved informed consent and authorization permitting release of personal health information must be signed by patient or guardian.
- Compliance with treatment for 3 weeks.
- Patients of childbearing age must have a negative pregnancy test.
Who cannot join
- Chemical or electrical burns.
- Patient with concomitant injury of head trauma, inhalation injury, or bone fracture.
- Pregnant or breast-feeding female.
- Known or suspected allergies to any of the components of MEBO.
- Suspicion or presence of active systemic or local cancer or tumor of any kind.
- Any immune deficiency disorder.
Show all 9Show fewer
- Suspected alcohol or drug abuse.
- Participation in another investigational drug study within 30 days prior to treatment start.
- If the donor site is less than 5 x 5-cm total area.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University Hospitals
Zagazig, Alsharkia, 44519
Mohammad S Alsabbahi, As. Lecturer, +201092007426, doctor.sabbahi@gmail.com
Mohammad S Alsabbahi, As. Lecturer
About this study
Official title: Randomized Single-center, Single-blind, Two-arm Parallel Group Trial of Using MEBO™ Dressing Versus Standard Care at Zagazig University Hospital in the Management of Donor and Recipient Sites of Split-thickness Skin Graft
40 Egyptian Cases with split-thickness skin graft receiving treatment at Zagazig University Hospitals. Study Duration:6 Months .Description of Agent or Moist Exposed Burn Ointment (MEBO).
Intervention:
Read more
Objectives: Primary: to determine the efficacy of MEBO versus standard care in improving the healing speed and re-epithelization process of skin graft donor and recipient sites. Secondary to determine the efficacy of MEBO in decreasing recovery time, rate of infections, rate of complications, total treatment costs and its effect on improving pain alleviation.
Description of Study Design: Arm 1 20 MEBO at sites of donor graft and recipient at time of operation and in dressing Arm 2 20 Standard cream Zagazig University Hospital (Antibiotics \& analgesics) Estimated Time to Complete 5 months
Read the detailed description
Background Information.
Skin grafting is a frequently used technique for covering skin defects in cases of row area. The technique evolved from use in the back alleys of India in pre-Christian times to become one of the most valuable clinical tools in modern surgery. There are several techniques for caring for the skin graft site to assure an adequate graft and prompt as well as wound healing.
The use of the split-thickness skin graft (STSG) as reconstructive technique is very common nowadays but this technique is usually a source of pain and discomfort for the patients and may cause significant morbidity and result in hypertrophic or even keloid scarring. The wound heals by a process of re-epithelialization which results in an epithelial cover usually within 7-14 days. The aim of graft management is to maintain an environment that promotes optimal healing and prevents morbidity, which can include pain and infection and ultimately delayed healing.
The dressing of donor and recipient sites which provides a protective barrier should be easy to apply, promote rapid re-epithelialization, and be pain free, infection free, and relatively inexpensive.
MEBO have been proved to have anti-inflammatory and anti-microbial effect due to the presence of - β sitosterol and berberine respectively. Many studies have reported that MEBO provides suitable moist environment needed for burn wounds for optimal healing and re-epithelialization without the need for wound closure by dressing. Also some studies have proved the efficacy of MEBO in secondary healing of partial thickness wounds, such as split thickness skin graft sites, with improved cosmetic results and better scar quality.
In cases of raw area, donor and recipient sites have been traditionally dressed with low-adherent wound contact paraffin gauze or antibiotic-impregnated tulle gras and covered by a secondary dressing made of gauze and absorbent padding.
These dressings are relatively inexpensive. However, during the peri-operative period, patients complain more often of discomfort or pain at the donor area than at the graft site itself besides, the poor cosmetic appearance of donor sites after healing is not readily accepted.
Because the basic pathology of burns closely mimics many aspects of skin graft donor sites, researchers are investigating using MEBO at donor and recipient sites.
Potential Risks
Due its pure and natural origin, MEBO have been reported to have no side effect or potential risks except rare cases of allergy and hypersensitivity.
Known Potential Benefits
MEBO has been proved to have a positive effect on improving healing process with rapid re-epithelialization. According to a recent study, the burn areas and graft sites were markedly less hyperemic and less pigmented and the final cosmetic appearance and patient satisfaction were also higher by using MEBO. The cases who used MEBO had better scar assessment and lower pain scale.
- Conditions
- Burns
- Being tested
- Moist Exposed Burn Ointment (MEBO), Zagazig
- Keywords
- Skin graft, Burn, MEBO, Wound dressing, Wound care, Raw Area
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moist Exposed Burn Ointment (MEBO)Drug
Also called MEBO cream
is a registered USA patented formulation since 1995. MEBO is pure herbal, natural in origin, containing beta-sitosterol phellodendron amurense, scutellaria baicalensis, coptis chinensis, pheretima aspergillum, Beeswax and sesame oil. 15, 19 The pharmacological effects are attributable to: beta-sitosterol, isolated from phellodendron amurense, flavonoids mainly baicalin isolated from scutellaria baicalensis, alkaloids mainly berberine, isolated from coptis chinensis, Beeswax and sesame oil.
ZagazigDrug
Also called Antibiotic & Analgesic
Standard care is an antibiotic ointment in combination of analgesic for relief of pain.
| Study group | Role | What they receive |
|---|---|---|
| Arm1 Mebo | Experimental | 20 : receiving Moist Exposed Burn Ointment (MEBO) at sites of donor graft and recipient at time of operation and in dressing Receives: Drug: Moist Exposed Burn Ointment (MEBO) |
| Arm2 Placebo | Placebo comparator | 20 : receiving Standard cream Zagazig University Hospital (Antibiotics \& analgesics) Receives: Drug: Zagazig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing Assessment
Standardized digital photographs will be taken of each site at the time of wound inspection, visit 1 and visit 2 then a plastic surgeon and a plastic resident will assessed the healing process blindly. These observers independently will rate the extent of re -epithelialization in each image as none, less than 50%, more than 50% but not complete, or complete. A numeric score was given to each rating as follows:
No re epithelialization=0, less than 50%=1, more than 50%=2, and complete=3. Hence, a higher score indicated a greater estimated extent of re -epithelialization.
Measured: 1 month
Secondary outcomes (6)
Recovery Time
Time from randomization till primary healing of 75% raw area surface are (BSA) and complete secondary healing of skin graft.
Measured: 1 month
Rate of Infections
Clinical assessment to detect early signs of infections and Culture for further investigations.
Measured: 2 weeks
Pain Assessment
Visual analogue scale (VAS) of pain (0-10); 0 is the minimum and 10 is the maximum Recording type and dose of administrated analgesics.
Measured: 2 weeks
Total Treatment Costs
Costs including (administrated medications, examinations costs, follow up visits after discharge).
Measured: 1 month
Rate of Complications
Rates of allergy, infection and bleeding rate
Measured: 1 week
Quality of Life
Health related quality of life (HRQL) Questionnaire
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohammad Alsabbahi, Zagazig University
- Investigators
- Muhammad H Abdel-All, Professor, Study director, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737943
- Sponsor's protocol ID
- 2579
- Acronym
- EMD-SCZ-SGS
- Status last verified
- Jan 2019
- First submitted
- 5 Apr 2016
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Atiyeh BS, Dham R, Kadry M, Abdallah AF, Al-Oteify M, Fathi O, Samir A. Benefit-cost analysis of moist exposed burn ointment. Burns. 2002 Nov;28(7):659-63. doi: 10.1016/s0305-4179(02)00075-x.
PubMed 12417161Mabrouk A, Boughdadi NS, Helal HA, Zaki BM, Maher A. Moist occlusive dressing (Aquacel((R)) Ag) versus moist open dressing (MEBO((R))) in the management of partial-thickness facial burns: a comparative study in Ain Shams University. Burns. 2012 May;38(3):396-403. doi: 10.1016/j.burns.2011.09.022. Epub 2011 Nov 17.
PubMed 22100189Carayanni VJ, Tsati EG, Spyropoulou GC, Antonopoulou FN, Ioannovich JD. Comparing oil based ointment versus standard practice for the treatment of moderate burns in Greece: a trial based cost effectiveness evaluation. BMC Complement Altern Med. 2011 Dec 1;11:122. doi: 10.1186/1472-6882-11-122.
PubMed 22132709Atiyeh BS, Ghanimeh G, Kaddoura IL, Ioannovich J, Al-Amm CA. Split-thickness skin graft donor site dressing: preliminary results of a controlled, clinical comparative study of MEBO and Sofra-Tulle. Ann Plast Surg. 2001 Jan;46(1):87-8. doi: 10.1097/00000637-200101000-00023. No abstract available.
PubMed 11192048Spear M, Bailey A. Treatment of skin graft donor sites with a unique transparent absorbent acrylic dressing. Plast Surg Nurs. 2009 Oct-Dec;29(4):194-200; quiz 201-2. doi: 10.1097/PSN.0b013e3181c4cdd9.
PubMed 20029295Weber RS, Hankins P, Limitone E, Callender D, Frankenthaler RM, Wolf P, Goepfert H. Split-thickness skin graft donor site management. A randomized prospective trial comparing a hydrophilic polyurethane absorbent foam dressing with a petrolatum gauze dressing. Arch Otolaryngol Head Neck Surg. 1995 Oct;121(10):1145-9. doi: 10.1001/archotol.1995.01890100055009.
PubMed 7546582Wiechula R. The use of moist wound-healing dressings in the management of split-thickness skin graft donor sites: a systematic review. Int J Nurs Pract. 2003 Apr;9(2):S9-17. doi: 10.1046/j.1322-7114.2003.00417.x.
PubMed 12694482Innes ME, Umraw N, Fish JS, Gomez M, Cartotto RC. The use of silver coated dressings on donor site wounds: a prospective, controlled matched pair study. Burns. 2001 Sep;27(6):621-7. doi: 10.1016/s0305-4179(01)00015-8.
PubMed 11525858Barnea Y, Amir A, Leshem D, Zaretski A, Weiss J, Shafir R, Gur E. Clinical comparative study of aquacel and paraffin gauze dressing for split-skin donor site treatment. Ann Plast Surg. 2004 Aug;53(2):132-6. doi: 10.1097/01.sap.0000112349.42549.b3.
PubMed 15269581Hormbrey E, Pandya A, Giele H. Adhesive retention dressings are more comfortable than alginate dressings on split-skin-graft donor sites. Br J Plast Surg. 2003 Jul;56(5):498-503. doi: 10.1016/s0007-1226(03)00195-4.
PubMed 12890465Giele H, Tong A, Huddleston S. Adhesive retention dressings are more comfortable than alginate dressings on split skin graft donor sites--a randomised controlled trial. Ann R Coll Surg Engl. 2001 Nov;83(6):431-4.
PubMed 11777142
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Single-center, Single-blind, Two-arm Parallel Group Trial of Using MEBO™ Dressing Versus Standard Care at Zagazig University Hospital in the Management of Donor and Recipient Sites of Split-thickness Skin Graft
- ClinicalTrials.gov ID
- NCT02737943
- Acronym / sponsor ID
- EMD-SCZ-SGS / 2579
- Conditions
- Burns
- Keywords
- Skin graft, Burn, MEBO, Wound dressing, Wound care, Raw Area
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- Mar 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 14 Apr 2016 (estimated)
- 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.
40 Egyptian Cases with split-thickness skin graft receiving treatment at Zagazig University Hospitals. Study Duration:6 Months .Description of Agent or Moist Exposed Burn Ointment (MEBO).
Intervention:
Objectives: Primary: to determine the efficacy of MEBO versus standard care in improving the healing speed and re-epithelization process of skin graft donor and recipient sites. Secondary to determine the efficacy of MEBO in decreasing recovery time, rate of infections, rate of complications, total treatment costs and its effect on improving pain alleviation.
Description of Study Design: Arm 1 20 MEBO at sites of donor graft and recipient at time of operation and in dressing Arm 2 20 Standard cream Zagazig University Hospital (Antibiotics \& analgesics) Estimated Time to Complete 5 months
Detailed description
Background Information.
Skin grafting is a frequently used technique for covering skin defects in cases of row area. The technique evolved from use in the back alleys of India in pre-Christian times to become one of the most valuable clinical tools in modern surgery. There are several techniques for caring for the skin graft site to assure an adequate graft and prompt as well as wound healing.
The use of the split-thickness skin graft (STSG) as reconstructive technique is very common nowadays but this technique is usually a source of pain and discomfort for the patients and may cause significant morbidity and result in hypertrophic or even keloid scarring. The wound heals by a process of re-epithelialization which results in an epithelial cover usually within 7-14 days. The aim of graft management is to maintain an environment that promotes optimal healing and prevents morbidity, which can include pain and infection and ultimately delayed healing.
The dressing of donor and recipient sites which provides a protective barrier should be easy to apply, promote rapid re-epithelialization, and be pain free, infection free, and relatively inexpensive.
MEBO have been proved to have anti-inflammatory and anti-microbial effect due to the presence of - β sitosterol and berberine respectively. Many studies have reported that MEBO provides suitable moist environment needed for burn wounds for optimal healing and re-epithelialization without the need for wound closure by dressing. Also some studies have proved the efficacy of MEBO in secondary healing of partial thickness wounds, such as split thickness skin graft sites, with improved cosmetic results and better scar quality.
In cases of raw area, donor and recipient sites have been traditionally dressed with low-adherent wound contact paraffin gauze or antibiotic-impregnated tulle gras and covered by a secondary dressing made of gauze and absorbent padding.
These dressings are relatively inexpensive. However, during the peri-operative period, patients complain more often of discomfort or pain at the donor area than at the graft site itself besides, the poor cosmetic appearance of donor sites after healing is not readily accepted.
Because the basic pathology of burns closely mimics many aspects of skin graft donor sites, researchers are investigating using MEBO at donor and recipient sites.
Potential Risks
Due its pure and natural origin, MEBO have been reported to have no side effect or potential risks except rare cases of allergy and hypersensitivity.
Known Potential Benefits
MEBO has been proved to have a positive effect on improving healing process with rapid re-epithelialization. According to a recent study, the burn areas and graft sites were markedly less hyperemic and less pigmented and the final cosmetic appearance and patient satisfaction were also higher by using MEBO. The cases who used MEBO had better scar assessment and lower pain scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1 Mebo | Experimental | Drug: Moist Exposed Burn Ointment (MEBO)20 : receiving Moist Exposed Burn Ointment (MEBO) at sites of donor graft and recipient at time of operation and in dressing |
| Arm2 Placebo | Placebo comparator | Drug: Zagazig20 : receiving Standard cream Zagazig University Hospital (Antibiotics \& analgesics) |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patients who will be managed using split-thickness skin graft.
- Donor skin grafts are harvested from a site in the thigh (a minimum of 5 x 5-cm total area).
- Intention for treatment at Zagazig University.
- Age between 2 \& 60 years.
- An approved informed consent and authorization permitting release of personal health information must be signed by patient or guardian.
Key exclusion criteria (9 listed)
- Chemical or electrical burns.
- Patient with concomitant injury of head trauma, inhalation injury, or bone fracture.
- Pregnant or breast-feeding female.
- Known or suspected allergies to any of the components of MEBO.
- Suspicion or presence of active systemic or local cancer or tumor of any kind.
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 |
|---|---|---|
| Moist Exposed Burn Ointment (MEBO)Also: MEBO creamis a registered USA patented formulation since 1995. MEBO is pure herbal, natural in origin, containing beta-sitosterol phellodendron amurense, scutellaria baicalensis, coptis chinensis, pheretima aspergillum, Beeswax and sesame oil. 15, 19 The pharmacological effects are attributable to: beta-sitosterol, isolated from phellodendron amurense, flavonoids mainly baicalin isolated from scutellaria baicalensis, alkaloids mainly berberine, isolated from coptis chinensis, Beeswax and sesame oil. | Drug | Arm1 Mebo |
| ZagazigAlso: Antibiotic & AnalgesicStandard care is an antibiotic ointment in combination of analgesic for relief of pain. | Drug | Arm2 Placebo |
Primary outcome
Wound Healing Assessment
Time frame: 1 month
Standardized digital photographs will be taken of each site at the time of wound inspection, visit 1 and visit 2 then a plastic surgeon and a plastic resident will assessed the healing process blindly. These observers independently will rate the extent of re -epithelialization in each image as none, less than 50%, more than 50% but not complete, or complete. A numeric score was given to each rating as follows: No re epithelialization=0, less than 50%=1, more than 50%=2, and complete=3. Hence, a higher score indicated a greater estimated extent of re -epithelialization.
6 secondary outcomes
Recovery Time
Time frame: 1 month
Rate of Infections
Time frame: 2 weeks
Pain Assessment
Time frame: 2 weeks
Total Treatment Costs
Time frame: 1 month
Rate of Complications
Time frame: 1 week
Quality of Life
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Background: PubMed 12417161Atiyeh BS, Dham R, Kadry M, Abdallah AF, Al-Oteify M, Fathi O, Samir A. Benefit-cost analysis of moist exposed burn ointment. Burns. 2002 Nov;28(7):659-63. doi: 10.1016/s0305-4179(02)00075-x.
- Background: PubMed 22100189Mabrouk A, Boughdadi NS, Helal HA, Zaki BM, Maher A. Moist occlusive dressing (Aquacel((R)) Ag) versus moist open dressing (MEBO((R))) in the management of partial-thickness facial burns: a comparative study in Ain Shams University. Burns. 2012 May;38(3):396-403. doi: 10.1016/j.burns.2011.09.022. Epub 2011 Nov 17.
- Background: PubMed 22132709Carayanni VJ, Tsati EG, Spyropoulou GC, Antonopoulou FN, Ioannovich JD. Comparing oil based ointment versus standard practice for the treatment of moderate burns in Greece: a trial based cost effectiveness evaluation. BMC Complement Altern Med. 2011 Dec 1;11:122. doi: 10.1186/1472-6882-11-122.
- Background: PubMed 11192048Atiyeh BS, Ghanimeh G, Kaddoura IL, Ioannovich J, Al-Amm CA. Split-thickness skin graft donor site dressing: preliminary results of a controlled, clinical comparative study of MEBO and Sofra-Tulle. Ann Plast Surg. 2001 Jan;46(1):87-8. doi: 10.1097/00000637-200101000-00023. No abstract available.
- Background: PubMed 20029295Spear M, Bailey A. Treatment of skin graft donor sites with a unique transparent absorbent acrylic dressing. Plast Surg Nurs. 2009 Oct-Dec;29(4):194-200; quiz 201-2. doi: 10.1097/PSN.0b013e3181c4cdd9.
- Background: PubMed 7546582Weber RS, Hankins P, Limitone E, Callender D, Frankenthaler RM, Wolf P, Goepfert H. Split-thickness skin graft donor site management. A randomized prospective trial comparing a hydrophilic polyurethane absorbent foam dressing with a petrolatum gauze dressing. Arch Otolaryngol Head Neck Surg. 1995 Oct;121(10):1145-9. doi: 10.1001/archotol.1995.01890100055009.
- Background: PubMed 12694482Wiechula R. The use of moist wound-healing dressings in the management of split-thickness skin graft donor sites: a systematic review. Int J Nurs Pract. 2003 Apr;9(2):S9-17. doi: 10.1046/j.1322-7114.2003.00417.x.
- Background: PubMed 11525858Innes ME, Umraw N, Fish JS, Gomez M, Cartotto RC. The use of silver coated dressings on donor site wounds: a prospective, controlled matched pair study. Burns. 2001 Sep;27(6):621-7. doi: 10.1016/s0305-4179(01)00015-8.
- Background: PubMed 15269581Barnea Y, Amir A, Leshem D, Zaretski A, Weiss J, Shafir R, Gur E. Clinical comparative study of aquacel and paraffin gauze dressing for split-skin donor site treatment. Ann Plast Surg. 2004 Aug;53(2):132-6. doi: 10.1097/01.sap.0000112349.42549.b3.
- Background: PubMed 12890465Hormbrey E, Pandya A, Giele H. Adhesive retention dressings are more comfortable than alginate dressings on split-skin-graft donor sites. Br J Plast Surg. 2003 Jul;56(5):498-503. doi: 10.1016/s0007-1226(03)00195-4.
- Background: PubMed 11777142Giele H, Tong A, Huddleston S. Adhesive retention dressings are more comfortable than alginate dressings on split skin graft donor sites--a randomised controlled trial. Ann R Coll Surg Engl. 2001 Nov;83(6):431-4.
- 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.
Muhammad H Abdel-All, Professor study director
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Moist Exposed Burn Ointment (MEBO) and Zagazig in people with Burns, run by Zagazig University at 1 site in Egypt.
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 7 inclusion and 9 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 29 Jan 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 Egypt. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Mohammad S Alsabbahi, As. Lecturer (+201092007426, doctor.sabbahi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing Assessment (time frame: 1 month). 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 NCT02737943, which also lists 11 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 29 Jan 2019.