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

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ClinicalTrials.gov Identifier: NCT02737943
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammad Alsabbahi, Zagazig University

Brief 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


Condition or disease Intervention/treatment Phase
Burns Drug: Moist Exposed Burn Ointment (MEBO) Drug: Zagazig Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : March 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

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 Name: 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 Name: Antibiotic & Analgesic




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. Rate of Infections [ Time Frame: 2 weeks ]
    Clinical assessment to detect early signs of infections and Culture for further investigations.

  3. 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.

  4. Total Treatment Costs [ Time Frame: 1 month ]
    Costs including (administrated medications, examinations costs, follow up visits after discharge).

  5. Rate of Complications [ Time Frame: 1 week ]
    Rates of allergy, infection and bleeding rate

  6. Quality of Life [ Time Frame: 1 month ]
    Health related quality of life (HRQL) Questionnaire



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Ages Eligible for Study:   2 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737943


Contacts
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Contact: Mohammad S Alsabbahi, As. Lecturer +201092007426 doctor.sabbahi@gmail.com

Locations
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Egypt
Zagazig University Hospitals Recruiting
Zagazig, Alsharkia, Egypt, 44519
Contact: Mohammad S Alsabbahi, As. Lecturer    +201092007426    doctor.sabbahi@gmail.com   
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         
Sponsors and Collaborators
Zagazig University
Investigators
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Study Director: Muhammad H Abdel-All, Professor Zagazig University

Publications:

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Responsible Party: Mohammad Alsabbahi, DR, Zagazig University
ClinicalTrials.gov Identifier: NCT02737943     History of Changes
Other Study ID Numbers: 2579
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mohammad Alsabbahi, Zagazig University:
Skin graft
Burn
MEBO
Wound dressing
Wound care
Raw Area
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Analgesics
Anti-Infective Agents
Antitubercular Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs