NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT

Not Applicable

Withdrawn

• Conditions: Surgical Site Infection; Breast Cancer; Wound Dehiscence
• Interventions: Device: Negative Pressure Wound Therapy

• Registration Number: NCT05338281
• Lead Sponsor: Western University, Canada

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 Timeline

• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-15
• Last Update Posted: 2023-04-19
• Study Start: 2023-09
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative Pressure Wound Therapy	Negative Pressure Wound Therapy	This group will receive the usual care of the abdominal donor wound following DIEP flap-based breast reconstruction surgery, AND the negative pressure wound therapy. The Prevena™ Incision Management System will be placed at the abdominal flap donor site after incision is closed. The Prevena™ will remain for up to 5 days, or until patient is discharged from the hospital.
Standard Dressing	Negative Pressure Wound Therapy	This group will receive the usual care of the abdominal donor wound following DIEP flap-based breast reconstruction surgery, and standard dressing which will be composed of gauze, secured with paper tape.

Primary Outcome Measures

Name	Time	Method
Postoperative Surgical Site Infection (SSI)	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 Outcome Measures

Name	Time	Method
The rate of seroma diagnosis	30 days after operation	The diagnosis of seroma will be completed by clinical exam and/or diagnostic imaging such as ultrasound or computed tomography.
The rate of wound dehiscence	30 days after operation	The diagnosis of wound dehiscence will be made by clinical exam.
The rate of hematoma diagnosis	30 days after operation	The diagnosis of hematoma will be completed by clinical exam and/or diagnostic imaging such as ultrasound or computed tomography.

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada