NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT

NCT05338281 | Withdrawn DMC FDA Device

• 1 other identifier: 120134
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Surgical Site Infection; Wound Dehiscence

Keywords

DIEP; Negative Pressure Wound Therapy; Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The rate of seroma diagnosis

  30 days after operation

• The rate of hematoma diagnosis

  30 days after operation

• The rate of wound dehiscence

  30 days after operation

Study Arms (2)

Negative Pressure Wound Therapy

EXPERIMENTAL

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

Standard Dressing

ACTIVE COMPARATOR

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

Interventions

Negative Pressure Wound Therapy DEVICE

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.

Also known as: Prevena™ Incision Management System

Negative Pressure Wound Therapy; Standard Dressing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are undergoing either immediate, or delayed reconstruction of the breast following mastectomy
• Patients going either unilateral or bilateral reconstruction

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Surgical Wound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Tanya DeLyzer, MD, FRCSC

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 21, 2022
• Study Start: September 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)