Negative Pressure Wound Therapy for Abdominal Incisions in DIEP Reconstructions: A RCT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Postoperative Surgical Site Infection (SSI)
Study Overview
Brief Summary
The current study is a single center randomized control trial that will examine the effect of closed incision negative pressure wound therapy (ciNPT) versus conventional dressing on abdominal incision in a deep inferior epigastric perforator (DIEP) flap based reconstruction. Patients will be followed by 30 days post-operatively to compare outcomes including the rate of surgical site infection, seroma, and the scar quality.
Detailed Description
The current study will examine the effect of closed incision negative pressure wound therapy on DIEP flap donor site. A total of 520 patients who are candidates for DIEP flap-based breast reconstruction will be included in this study, and randomly divided into the two groups. Those with contraindications to ciNPT will be excluded. The surgical consultation and procedure will be conducted same for both groups. Patients will be followed by 30 days post-operatively. Outcome measures will include incidence of surgical site infection, wound dehiscence, seroma, hematoma, delayed wound healing, and surgical scar quality.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who are undergoing either immediate, or delayed reconstruction of the breast following mastectomy
- •Patients going either unilateral or bilateral reconstruction
Exclusion Criteria
- •Patients who are not candidates for DIEP flap based breast reconstruction, such as those with insufficient abdominal tissue, or unfit for the surgery will be excluded from this study. -
- •Patients who have contraindications to the ciNPT
- •Patients who have pre-existing conditions that may confound results such as bleeding disorder or therapeutic anticoagulation will be excluded from the study.
- •Patients who do not want to carry an additional canister from the ciNPT during the initial recovery phase will be excluded from the study.
Outcomes
Primary Outcomes
Postoperative Surgical Site Infection (SSI)
Time Frame: 30 days after operation
The post-operative SSI at the abdomen will be determined following the Center for Disease Control (CDC) criteria. This includes one or more of the following: 1\. Purulent drainage from the incision, 2. Organisms identified from an aseptically-obtained specimen 3. Superficial incision with one of the following signs or symptoms localized pain or tenderness; localized swelling; erythema; or heat. d. Diagnosis of a superficial incisional SSI by a physician or designee
Secondary Outcomes
- The rate of seroma diagnosis(30 days after operation)
- The rate of wound dehiscence(30 days after operation)
- The rate of hematoma diagnosis(30 days after operation)
Investigators
Tanya DeLyzer
Principal Investigator
Western University, Canada