A Randomized, Prospective Evaluation of Negative Pressure Wound Therapy on Abdominal Donor Site in Free Flap Breast Reconstruction in Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Wound healing complications
研究概览
简要总结
This trial studies the safety and how well negative pressure wound therapy works in healing the abdominal incision in obese patients undergoing free flap breast reconstruction surgery. Using negative pressure wound therapy (NPWT) instead of standard dressing (bandages) may improve wound healing at the surgical site in the abdomen where tissue was collected for breast reconstruction surgery.
详细描述
PRIMARY OBJECTIVES:
I. Determine the impact of negative pressure wound therapy on wound healing as measured by wound dehiscence rate.
II. Long-term follow-up on wound healing complications.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive wound care with a standard dressing (bandage) after surgery for 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing a free abdominal flap, including a superficial inferior epigastric artery (SIEA), deep inferior epigastric artery perforator (DIEP), or muscle-sparing transverse rectus abdominus myocutaneous (MS-TRAM) flap for breast reconstruction.
- •Patients are willing and able to give consent.
- •Body mass index (BMI) greater than or equal to 30.0.
排除标准
- •Patients who are unable to provide consent.
- •Patients who are suspected or known to be pregnant.
- •Known allergy to topical adhesives.
研究组 & 干预措施
Group I (wound care with a standard dressing)
Patients receive wound care with a standard dressing (bandage) after surgery for 7 days.
干预措施: Wound Care Management (Procedure)
Group II (NPWT)
Patients receive NPWT after surgery for 7 days.
干预措施: Negative Pressure Wound Therapy (Procedure)
结局指标
主要结局
Wound healing complications
时间窗: Up to 3 months
Will measure and compare the wound healing outcomes of patients. All adverse events will be identified, graded for severity and assigned causality, reported to the required entities, and compiled for periodic review. After assigning causality, the principal investigator will decide the course of action for the study participant.
Rate of wound dehiscence
时间窗: Up to 3 months
Will measure and compare the wound healing outcomes of patients. All adverse events will be identified, graded for severity and assigned causality, reported to the required entities, and compiled for periodic review. After assigning causality, the principal investigator will decide the course of action for the study participant.
次要结局
未报告次要终点