MariGen Fish Skin Compared to Cadaver Skin as a Temporary Covering for Full Thickness Burns: An Early Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Kerecis Ltd.
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Proportions of wounds that have healed
研究概览
简要总结
Objectives and rationale: Optimal burn management involves removing all the dead or burned tissue as early as feasible and cover with an autograft called split thickness skin graft (STSG) taken from the patient. This procedure creates a new wound on the patient and sometimes, when the burn covers very large portion of the patient body, there is a lack of healthy skin to use for this purpose. Under those circumstances, donated cadaver skin is used as a temporary coverage until the patient´s own donor site wound has healed enough to be used again.
The proposed clinical study aims to determine if treatment with fish skin is an alternative to cadaver skin as a temporary coverage for debrided full-thickness burns prior to STSG in terms of autograft take, time to heal, quality of healing (scarring), pain and adverse effects.
详细描述
Mortality after severe burns has diminished during the last decades and survival is no longer considered the primary end point of care. More attention is paid to the final functional and cosmetic outcome of the affected area but outcomes are still far from optimal. For the time being, one of the main goals in burn treatment is to achieve reduced scar formation from the time of injury. A temporary or permanent covering of the wound bed should be achieved at the time of excision. In burn wounds the gold standard is to use split thickness skin graft, or STSG, which includes epidermis, basement membrane, and a part of upper dermis. Yet the use of skin grafts has many shortcomings: there is only a limited amount of skin available for grafting, the donor sites are susceptible to infections, to pain, to pigmentation changes, and to scarring especially when re harvested. Therefore, for complicated burns, initial treatment is often with temporary coverage where cadaver skin has been the accepted standard of care.
In recent years there has been progress in the development of advanced wound care products. This has resulted in a third generation of wound treatment, known as acellular dermal grafts or skin substitutes.
Aims The goal of this clinical trial is to demonstrate that fish skin is an alternative to cadaver skin as early cover before STSG in burn wounds. This trial will be open to patients who are scheduled to receive meshed STSG of any ratio. Fish skin or cadaver skin will be applied after initial debridement in order to prepare the wound area for STSG.
5 to 10 patients will be prospectively enrolled and two burn sites on their body will randomized to initial treatment after debridement with either fish skin or cadaver skin for 7+/-3 days. After the initial treatment, the test sites will be grafted with STSG.
The histological differences and the functional outcomes will be assessed for 12 months.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The burn wound trial area consists of two adjacent burn wound sites. The randomization will happen on the day of debridement. The test areas will be randomized to treatment so that one side receives early cover with fish skin and the other one with SOC. Treating physician will be aware of which product is being used on each site as temporary cover before grafting, but will not give this information to the patient. Prior to grafting, a blinded burn surgeon investigator will assess the burn wound bed. He/she will only have a subject number. The same procedure is used for the secondary endpoints of local reactions. Reassessment done by treating physician before STSG cannot be blinded as it is obvious what temporary treatment the test areas have received. Photos taken of wounds during the treatment (where products are not visible) will be judged blind by additional investigators. Scar assessment at 3 and 12 months via the Vancouver Scar Sale will also be fully blinded.
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant or legally authorized representative is willing and able to give informed consent for participation in the clinical trial.
- •Patients from 22 to 75 years of age. Acute full thickness burn wounds outside the following areas; facial, genital and across joints, requiring widely meshed skin grafting or staging of STSG treatment due to insufficient healthy donor sites.
- •Maximal Total Body Surface Area (TBSA) of 50% full thickness burns
- •Able (in the Investigators opinion) and willing to comply with all clinical trial requirements.
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the clinical trial.
排除标准
- •Declined consent
- •Immunocompromised patients or patients receiving immunosuppressive therapy
- •Presently participating in another clinical trial
- •Patient actively taking glucocorticoid or cytostatic medications
- •Persons with immune deficiency because of disease or iatrogenic-
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the clinical trial, or may influence the result of the clinical trial, or the participant's ability to participate in the clinical trial.
- •Patient has known allergy to fish. (Shell fish allergy is not a contraindication)
- •Exclusion areas are, facial, genital and across joints.
- •Female participants who are pregnant, breast feeding or planning pregnancy during the course of the clinical trial
结局指标
主要结局
Proportions of wounds that have healed
时间窗: At 3 weeks days after STSG
Wounds which have reached at least 95% epithelialization
次要结局
- Incidence of hematoma(At all treatments appointments until 3 weeks after STSG)
- Dermatitis(At all treatments appointments until 3 weeks after STSG)
- Ease-of-use(Day 0 when grafts are initially applied after debridement)
- Percentage of wound area exhibiting graft failure(At 2 weeks after STSG)
- Full epithelialization of wound(At 2 weeks after STSG)
- Scarring estimated with the Vancouver Scar Scale (VSS)(At 12 months after STSG)
- Average number of antibiotics treatments per patient(At all treatments appointments until 4 weeks after STSG)
- Pain assessed by the Visual Analog Scale (VAS) before and after dressing changes(At all treatments appointments until 3 weeks after STSG)
- Bleeding time(At all treatments appointments until 3 weeks after STSG)
- Inflammatory profiling of wound punch biopsies as assessed by mass spectrometry(Before STSG, 2 and 3 weeks and 12 months after STSG)
- Inflammation profiling of wound punch biopsies as assessed by histology(Before STSG, 2 and 3 weeks and 12 months after STSG)