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
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Wound Healing Assessment
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Arm1 Mebo
20 : receiving Moist Exposed Burn Ointment (MEBO) at sites of donor graft and recipient at time of operation and in dressing
干预措施: Moist Exposed Burn Ointment (MEBO) (Drug)
Arm2 Placebo
20 : receiving Standard cream Zagazig University Hospital (Antibiotics & analgesics)
干预措施: Zagazig (Drug)
结局指标
主要结局
Wound Healing Assessment
时间窗: 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.
次要结局
- Rate of Complications(1 week)
- Pain Assessment(2 weeks)
- Total Treatment Costs(1 month)
- Recovery Time(1 month)
- Rate of Infections(2 weeks)
- Quality of Life(1 month)
研究者
Mohammad Alsabbahi
DR
Zagazig University