Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02737943
Other study ID # 2579
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 2016
Est. completion date July 2019

Study information

Verified date January 2019
Source Zagazig University
Contact Mohammad S Alsabbahi, As. Lecturer
Phone +201092007426
Email doctor.sabbahi@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date July 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender All
Age group 2 Years to 60 Years
Eligibility Inclusion Criteria:

1. Patients who will be managed using split-thickness skin graft.

2. Donor skin grafts are harvested from a site in the thigh (a minimum of 5 x 5-cm total area).

3. Intention for treatment at Zagazig University.

4. Age between 2 & 60 years.

5. An approved informed consent and authorization permitting release of personal health information must be signed by patient or guardian.

6. Compliance with treatment for 3 weeks.

7. Patients of childbearing age must have a negative pregnancy test.

Exclusion Criteria:

1. Chemical or electrical burns.

2. Patient with concomitant injury of head trauma, inhalation injury, or bone fracture.

3. Pregnant or breast-feeding female.

4. Known or suspected allergies to any of the components of MEBO.

5. Suspicion or presence of active systemic or local cancer or tumor of any kind.

6. Any immune deficiency disorder.

7. Suspected alcohol or drug abuse.

8. Participation in another investigational drug study within 30 days prior to treatment start.

9. If the donor site is less than 5 x 5-cm total area.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Moist Exposed Burn Ointment (MEBO)
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.
Zagazig
Standard care is an antibiotic ointment in combination of analgesic for relief of pain.

Locations

Country Name City State
Egypt Zagazig University Hospitals Zagazig Alsharkia

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (11)

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. — View Citation

Atiyeh 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. — View Citation

Barnea 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. — View Citation

Carayanni 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. — View Citation

Giele 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. — View Citation

Hormbrey 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. — View Citation

Innes 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. — View Citation

Mabrouk A, Boughdadi NS, Helal HA, Zaki BM, Maher A. Moist occlusive dressing (Aquacel(®) Ag) versus moist open dressing (MEBO(®)) 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. — View Citation

Spear 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. — View Citation

Weber 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. — View Citation

Wiechula 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. Review. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
1 month
Secondary Recovery Time Time from randomization till primary healing of 75% raw area surface are (BSA) and complete secondary healing of skin graft. 1 month
Secondary Rate of Infections Clinical assessment to detect early signs of infections and Culture for further investigations. 2 weeks
Secondary 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. 2 weeks
Secondary Total Treatment Costs Costs including (administrated medications, examinations costs, follow up visits after discharge). 1 month
Secondary Rate of Complications Rates of allergy, infection and bleeding rate 1 week
Secondary Quality of Life Health related quality of life (HRQL) Questionnaire 1 month
See also
  Status Clinical Trial Phase
Completed NCT05023135 - DeepView SnapShot Portable (DV-SSP): Device Training Study
Completed NCT05276869 - Reliability and Feasibility of WeeFIM Instrument to Measure Functional Independence in Pediatric Burns
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Not yet recruiting NCT06076031 - Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing N/A
Recruiting NCT05084248 - Vitamin D Deficiency in Adults Following a Major Burn Injury Phase 4
Completed NCT03113253 - TRANexamic Acid to Reduce Bleeding in BURN Surgery Phase 4
Recruiting NCT04090424 - Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT03159182 - Study of Silicone Material Inserts To Treat Burn Scars N/A
Recruiting NCT02904941 - Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns N/A
Completed NCT02681757 - Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT01437852 - StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns Phase 1
Completed NCT01214811 - Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing Phase 3
Completed NCT01061502 - Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds Phase 1/Phase 2
Terminated NCT00822796 - Thermogard™ Efficacy Trial N/A
Terminated NCT00634166 - Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group Phase 4
Terminated NCT00824681 - Effect of Music Therapy on Families of Burn Patients Phase 1
Terminated NCT00464386 - Continuous Glucose Monitoring (POC) in the ICU N/A
Withdrawn NCT00216983 - Proline Metabolism in Severely Burned Patients: Effect of Modulated Parenteral Feeding N/A