NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT

Study Overview
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Brief Summary
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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
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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.

Official Title
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Negative Pressure Wound Therapy for Abdominal Incisions in DIEP Reconstructions: A RCT

Conditions
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Breast Cancer, Surgical Site Infection, Wound Dehiscence

Intervention / Treatment
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* Device: Negative Pressure Wound Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative Pressure Wound Therapy<br>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. | Device: Negative Pressure Wound Therapy<br>* The negative pressure wound therapy will be placed in addition to usual care of the abdominal donor site, such as closure with resorbable sutures, drain placements.<br>* Other names: Prevena™ Incision Management System;|
| Active Comparator: Standard Dressing<br>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. | Device: Negative Pressure Wound Therapy<br>* The negative pressure wound therapy will be placed in addition to usual care of the abdominal donor site, such as closure with resorbable sutures, drain placements.<br>* Other names: Prevena™ Incision Management System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Surgical Site Infection (SSI) | 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 | 30 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of seroma diagnosis | The diagnosis of seroma will be completed by clinical exam and/or diagnostic imaging such as ultrasound or computed tomography. | 30 days after operation | 
| The rate of hematoma diagnosis | The diagnosis of hematoma will be completed by clinical exam and/or diagnostic imaging such as ultrasound or computed tomography. | 30 days after operation | 
| The rate of wound dehiscence | The diagnosis of wound dehiscence will be made by clinical exam. | 30 days after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DIEP, Negative Pressure Wound Therapy, Breast Reconstruction