A Comparison of OASIS Wound Matrix With Approved Dressings for Split Thickness Skin Graft Donor Sites
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Time to Heal
研究概览
简要总结
The investigators objective is to compare OASIS wound matrix with other commonly used dressings available for the donor site in split thickness skin grafting in order to determine which dressing provides the best outcome based on pain level, time to healing and aesthetic outcome.
详细描述
Investigators seek to compare Oasis wound matrix with Tegaderm and Xeroform in order to determine whether advantages exist in one or more of the dressing types that are approved and currently used for split-thickness skin graft donor site dressings.
Patients will be randomly assigned to one of the three treatment groups and followed up post-operatively and treated as per current standard of care.
Data to be collected and analyzed includes: patient age, co-morbid illnesses, medication, skin-graft donor location, skin-graft donor area, STSG thickness, infection rate, complications involving the donor site, post-operative pain score every morning until hospital discharge, healing rate, photographs of the donor site immediately post-operatively and then at routine follow-up appointments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled to undergo split thickness skin grafting
- •patients able to consent without a proxy
排除标准
- •confounding medical conditions
- •previous skin grafting from site
- •prior use of biological skin substitute on site
研究组 & 干预措施
OASIS® wound matrix
OASIS wound matrix is a biologic extracellular matrix derived from porcine small intestine submucosa. Some components of OASIS wound matrix are similar to human dermis including types of collagens, elastin, glycoproteins and proteoglycans. In addition, OASIS wound matrix retains some growth factors that have been suggested to aid in the wound healing process. It is a FDA approved wound dressing indicated for use in a variety of ulcers, abrasions and surgical wounds.
干预措施: OASIS® wound matrix (Device)
Tegaderm™(Absorbant, 3M)
Transparent dressing allows for wound monitoring without changing the dressing Clear design takes the guesswork out of application over the wound Novel acrylic polymer pad technology designed to handle low to moderate wound drainage. No dressing breakdown in the wound. Low friction surface minimizes potential for friction and shear. Allows for gentle removal from skin. Barrier to external contaminants, body fluids, bacteria and viruses.
干预措施: Tegaderm™(Absorbant, 3M) (Other)
Xeroform™
Xeroform™ Occlusive Petrolatum Gauze. 3% Bismuth Tribromophenate in a special petrolatum blend on fine mesh gauze. Non-adherent. Clings and conforms to all body contours.
干预措施: Xeroform™ (Other)
结局指标
主要结局
Time to Heal
时间窗: 7-21 days
Patient will be followed up during routine post-operative appointments at the clinic weekly to check the healing process of the donor site wound.
次要结局
- Aesthetic Outcome(1-12 weeks)
- Pain intensity measure(7 days)