Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Percentage of Wound Re-epithelialization
研究概览
简要总结
This study evaluates a novel micrografting technique to see how it will influence the healing rate and cosmetic result of second intention wounds. The graft harvesting and micrografting process was designed by MoMelan Technologies The Epidermal Expansion System, which is composed of a commercially available Blister Generation Device and the Microblister Generation and Excision Device (MBGED), will generate an array of small microblisters and transfer the micrografts to a sterile dressing (Tegaderm™ - an FDA approved wound dressing) for application to the subject's surgical area. The investigators predict that applying expanded micrografts to wounds that otherwise would have healed by second intention alone will hasten healing and possible reduce scarring.
详细描述
Participants with a scalp wound s/p Mohs procedure will be randomized to a micrografting technique intervention or to no intervention/heal with secondary intention alone (control). Intervention consists of harvesting skin micrografts (1.75mm) from pigmented skin using the Microblister generation and excision device and transfer the micrografts to a sterile dressing for application to the participants scalp wound. Percent wound re-epithelialization will be compared between two groups.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 40-75 years old
- •Status post Mohs procedure on the scalp with a wound that would otherwise be allowed to heal by second intention
- •Superficial would-at deepest of 2.0 mm or to superficial fat, but not deep to muscle
- •Area is less then 6 cm2 (wound diameter less than 2cm)
排除标准
- •Female patients who are breastfeeding, pregnant, or planning to become pregnant
- •Abnormal bleeding observed during initial Mohs procedure that would suggest a higher risk of post-operative bleeding
- •Subjects currently on immunosuppressive medications, chemotherapy or a cytotoxic agent
- •Participation in another interventional study with potential exposure to an investigational drug within past 30 days or planned study entry within 90 days after study entrance
结局指标
主要结局
Percentage of Wound Re-epithelialization
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
Alexandra Kimball
Director, Clinical Unit for Research Trials in Skin
Massachusetts General Hospital