Effect of Mebo Dressing Versus Standard Care on Managing Donor and Recipient Sites of Split-thickness Skin Graft (EMD-SCZ-SGS)

January 25, 2019 updated by: Mohammad Alsabbahi, Zagazig University

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:

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Alsharkia
      • Zagazig, Alsharkia, Egypt, 44519
        • Recruiting
        • Zagazig University Hospitals
        • Contact:
        • Principal Investigator:
          • Mohammad S Alsabbahi, As. Lecturer
        • Sub-Investigator:
          • Mohamed HA Elsayed, As. Lecturer
        • Sub-Investigator:
          • Mohamed AM Ebrahim, As. Lecturer
        • Sub-Investigator:
          • Sameh M Hassan, Intern
        • Sub-Investigator:
          • Mohamed H Abdelhady, Student
        • Sub-Investigator:
          • Mohamed A Salama, Student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 58 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm1 Mebo
20 : receiving Moist Exposed Burn Ointment (MEBO) at sites of donor graft and recipient at time of operation and in dressing
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.
Other Names:
  • MEBO cream
Placebo Comparator: Arm2 Placebo
20 : receiving Standard cream Zagazig University Hospital (Antibiotics & analgesics)
Drug: Zagazig
Standard care is an antibiotic ointment in combination of analgesic for relief of pain.
Other Names:
  • Antibiotic & Analgesic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery Time
Time Frame: 1 month
Time from randomization till primary healing of 75% raw area surface are (BSA) and complete secondary healing of skin graft.
1 month
Rate of Infections
Time Frame: 2 weeks
Clinical assessment to detect early signs of infections and Culture for further investigations.
2 weeks
Pain Assessment
Time Frame: 2 weeks
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
Total Treatment Costs
Time Frame: 1 month
Costs including (administrated medications, examinations costs, follow up visits after discharge).
1 month
Rate of Complications
Time Frame: 1 week
Rates of allergy, infection and bleeding rate
1 week
Quality of Life
Time Frame: 1 month
Health related quality of life (HRQL) Questionnaire
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Study Director: Muhammad H Abdel-All, Professor, Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Actual)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2579

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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