The Effect of Allogeneic Human Fat-Derived Extract on Skin Graft Donor Site Wound Healing
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical evaluation
研究概览
简要总结
This study will evaluate the effect of an allogeneic adipose tissue extract on wound healing and scar maturation. Thirty adult patients scheduled for skin graft surgery will be enrolled. Each patient will have two skin graft donor sites harvested. One skin graft donor site wound will be treated topically with the adipose tissue extract, applied immediately after harvesting and reapplied on Day 3, while the other skin graft donor site wound will receive standard care. The main outcome is the time to complete epithelialization of the wound, as confirmed by investigators and independent reviewers. Secondary measures include wound characteristics, scar formation and scar quality, and monitoring of adverse events, such as wound deterioration.
详细描述
Cell-free preparate of human adipose tissue is intended to be used in the human body for its original purpose to supplement and replace local extracellular matrix deficiencies in soft tissue, including skin. The tissue product provides a temporary conductive environment into the injured area. This facilitates the ability of local cells to re-populate the damaged soft tissue and skin area, thereby enabling the deposition of extracellular matrix and repair of the tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants and outcome independent evaluators are blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Wound of at least 10 cm3 with an indication of skin graft surgery (two skin grafts harvested and used)
- •Adult (age 18 years or more)
- •Able and willing to give informed consent
- •Reasonably accessible to the study clinic and compliant to wound treatment
排除标准
- •Known allergy to any of the preparation used in the study (Tience)
- •Systemic cancer (does not include carcinoma in situ of the cervix or local skin cancers such as basiloma)
- •Pregnancy or nursing
- •Those who withhold consent
- •Active infection on the receptor site, donor site or sepsis
- •Any other serious disease likely to compromise the outcome of the trial, such as critical renal disease (creatinine greater than 300 mmol/l)
- •Those living at such a distance from the clinic as would make frequent assessment visits inappropriately expensive and/or impractical.
- •Those with conditions, which tend to limit a patient´s ability or willingness to restrict activities or comply with the instructions during the treatment and follow-up period.
研究组 & 干预措施
Adipose tissue extract treatment
Study participants will have two skin graft donor sites harvested. One donor site will be treated topically with adipose tissue extract immediately after harvesting and again on Day 3. The other skin graft donor site wound will receive standard of care, following the hospital's Current Care Guidelines.
干预措施: Topical treatment (Procedure)
结局指标
主要结局
Clinical evaluation
时间窗: Day 3, Day 7, Day 14, Day 60
The primary efficacy end point will the wound healing time during this study period, in days. Healing will be defined as complete epithelialization (mm paper, photographs), confirmed by an investigator and independent evaluators. The comparison will be made between the donor site treated with allogeneic adipose tissue extract (ATE) and the untreated donor site (standard care) within the same participant.
The number adverse events, including deterioration of the wounds during the study.
时间窗: Day 3, Day 7, Day 14, Day 60
The primary safety end points will be the number adverse events, including deterioration of the wounds during the study. * Adverse events, including deterioration of wounds * Severe wound complications (necrosis, infection)
Clinical evaluation
时间窗: Day 3, Day 7, Day 14
The donor site wound physical characteristics will be recorded: moisture, colour, infection and hypergranulation
Clinical imaging
时间窗: Post op, Day 3, Day 7, Day 14, and Day 60
Digital photographs will be taken to document the progression of wound healing. One or two blinded plastic surgeons, with no conflicts of interest, will evaluate the donor site wounds and scars based on these photographs. They will assess and compare the donor sites treated with allogeneic adipose tissue extract (ATE) and those treated with standard care, as well as the resulting scars, using the photographic documentation.
Clinical evaluation
时间窗: Day 60
Scar scaling, modified Vancouver burn scale consists of six items. All items are scored on a scale ranging from 1 ('like normal skin') to 3 ('worst scar imaginable'). • Vascularity category: pale, pink, red, normal • Pigmentation category: hypo, hyper, normal • Height: plane, depressed, elevated • Matte vs. shine: shine, matte • Contour: forms part of the adjacent skin, small indentation or invagination • Texture: normal, barely palpable, rough, indented
次要结局
- Pain Intensity Measure(Day 3, Day 7, Day 14)
- Clinical evaluation(Day 60)
- Fever (only symptomatic patients)(Day 3, Day 7, and Day 14)