Coupling Negative Pressure Wound Therapy With Instillation for Optimal Graft Take: Randomized Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Percentage of Skin Graft Take at Four Days Post-Operative
研究概览
简要总结
The objective of this study is to compare standard negative pressure wound therapy with negative pressure wound therapy coupled with instillation for optimal skin graft take. Either the V.A.C ULTA NPWT or V.A.C. VeraFlo Therapy systems with normal saline will be applied intra-operatively to split-thickness skin grafts of upper and lower extremity wounds and kept in place for a duration of four days. Following completion of four days, the skin graft with be assessed for percentage of take/adherence and will be covered with simple gauze dressings as needed.
详细描述
Past studies have investigated the use of NPWT for post-operative skin graft treatment and shown superior outcomes regarding graft take and need for repeat grafting when compared with standard gauze dressing. However, to date, no study has compared standard NPWT to NPWT coupled with instillation for post-operative treatment of extremity skin grafts. This study is designed as a randomized, controlled pilot study to compare treatment standard NPWT with NPWT coupled with instillation on skin graft take.
Patients will be selected based on inclusion criteria and randomized to either the treatment (NPWT coupled with instillation) or the control group (standard NPWT). Depending on the group to which they are randomized to, patients will have standard NPWT or NPWT coupled with instillation applied intra-operatively after application of split thickness skin graft for treatment of extremity wound.
Patients randomized to control group will receive V.A.C Ulta NPWT at 125mmHg continuous pressure for duration of four days.
Patients randomized to treatment group will receive V.A.C VeraFlo therapy. Protocol will consist of the following:
- Instillation solution: normal saline
- Dwell/soak time: 30 seconds
- Cycle Time: 4 hours
- Pressure: 125mmHg
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been offered split-thickness skin graft for treatment of an extremity wound.
排除标准
- •Abnormal healing (diagnosed with connective tissue disorder)
- •Uncontrolled diabetes mellitus (HgbA1c >9)
结局指标
主要结局
Percentage of Skin Graft Take at Four Days Post-Operative
时间窗: 4 days from intervention
percentage of skin graft take at time of wound vac take down (4 days post-op)
次要结局
- Percentage of Skin Graft Take at Thirty Days Post-Operative(30 days from intervention)