Molecular, Histologic, and Clinical Analysis of Negative Pressure Wound Therapy (NPWT) for Split-thickness Skin Graft (STSG) Donor Sites
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Tissue sample: re-epithelialization and granulation percentage
研究概览
简要总结
The purpose of this single-center, randomized, prospective cohort study is to evaluate the clinical outcome and negative-pressure wound therapy (NPWT) mediated modulation of the biologic milieu of a modified NPWT dressing on split-thickness skin graft (STSG) donor sites.
详细描述
The investigators have designed a prospective randomized trial in which subjects will be assigned to a modified negative-pressure wound therapy (NPWT) dressing or standard moist dressing. The investigators will measure the percentage of re-epithelization at set postoperative time intervals using digital photography, pain using the visual analog scale (VAS), and healing quality using the Vancouver Scar Scale (VSS). The investigators hypothesize that the NPWT will lead to less pain and increased re-epithelization in a shorter postoperative time course. This specific aim seeks to prove/disprove that patients who receive a modified NPWT dressing perceive the advantage with improved healing, pain, shorter length of stay, and other wound symptoms related to delayed donor site wound healing.
The donor site for STSGs provides a consistent model of superficial wounds that offers the opportunity to study both mechanisms of wound healing and potential mechanisms of action of NPWT. In patients undergoing both standard dressings and NPWT, the investigators will sample the wound exudate and perform microbiopsies of the healing wound at fixed intervals and perform histologic and molecular analysis in order to quantify the degree of re-epithelization and the trophic and inflammatory profile of the healing wound.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60
- •Both genders are eligible for study
- •Written consent obtained from the subject or agent
- •Donor site wounds must not exceed 5% total body surface area (TBSA)
- •Subject must be receiving a split-thickness skin graft (STSG)
- •Donor site is amenable to either NPWT or standard of care (occlusive dressing)
- •Ability to comply with necessary wound care/follow up
排除标准
- •Age <18 years
- •Subject has been diagnosed with Diabetes
- •Subject is a smoker
- •Subject takes steroids
- •Subject takes immunosuppressive medications
- •Subject with immunosuppressive disorders
- •Donor site wounds that exceed 5% total body surface area (TBSA)
- •Subject has sensitivity to silver or acrylic adhesives
- •Inability to comply with necessary wound care/follow up.
结局指标
主要结局
Tissue sample: re-epithelialization and granulation percentage
时间窗: Assessed up to 14 days
Tissue samples will be fixed and processed for hematoxylin and eosin (H\&E) staining and analyzed microscopically for re-epithelialization percentage.
Tissue sample: epidermal thickness
时间窗: Assessed up to 14 days
Tissue samples will be fixed and processed for hematoxylin and eosin (H\&E) staining and analyzed microscopically for epidermal thickness.
Pain as measured by visual analog scale (VAS).
时间窗: Assessed up to 14 days
Wound exudate: mRNA expression
时间窗: Assessed up to 14 days
Wound exudate and tissue lysate will be subjected to polymerase chain reaction (PCR) for semi-quantitative analysis of mRNA expression.
Wound healing rate (re-epithelialization)
时间窗: Assessed up to 1 month
Evaluated by the investigator and by a blinded expert using photographs.
Wound exudate: protein content
时间窗: Assessed up to 14 days
Quantitative enzyme-linked immunosorbent assay (ELISA) will allow analysis of target protein content.
次要结局
- Wound Healing Quality(Assessed up to 1 month postoperatively)
研究者
Indranil Sinha
Assistant Professor of Surgery, Harvard Medical School, Division of Plastic Surgery
Brigham and Women's Hospital