Hospital based Interventional Study to compare Negative Pressure wound Therapy and Conventional Wound Therapy in Open Post-Operative Abdominal Wounds.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Gross and Percentage Area Reduction of wound.
研究概览
简要总结
This study is a randomized, open label, parallel group, single- centre trial comparing the safety and efficacy of Negative Pressure Wound Therapy (at -125mmhg continiously for 5 days per cycle) and Conventional Wound Therapy once daily in 75 hospitalized patients with Post Operative Open Abdominal Wounds with intact fascial sheath, that will be conducted in a single tertiary care center in Eastern India. The primary outcome measure will be Gross and Percentage Area reduction of wound at Ten Days i.e. after two cycles of therapy. The secondary outcome will be Gross and Percentage Area reduction of wound at Five Days i.e. after single cycle of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participant/Authorised Representative is willing and able to provide written informed consent.
- •2.Diagnosis of post-surgical subcutaneous abdominal wound healing impairment, i.e. with intact fascia.
- •3.Minimum wound size eligible for the application of the intervention, i.e. where NPWT is feasible (fixed at 10 sq.
- •cm for this trial.).
排除标准
- •1.Age less than 18years.
- •2.A patient unable or unwilling to sign the Informed Consent Form, or to have their legally authorised representative act as a surrogate.
- •3.A patient unable or unwilling to comply with the protocol and study-related requirements.
- •4.Presence of Fascial defect of abdomen.
- •5.Necrotic tissue with eschar present.
- •6.Enteric or other Fistulae if present, or discharge containing Enteric content.
- •7.Possibility of Malignancy in wound.
结局指标
主要结局
Gross and Percentage Area Reduction of wound.
时间窗: Gross and Percentage Area Reduction of wound at Day 10 after 2 cycles of therapy.
次要结局
- Quality of Life assessment using Visual Analog Scale(At Day 10)
- Adverse events(At every Dressing Change)
研究者
DEBARAJ SHOME PURKAYASTHA
IPGMER and SSKM Hospital