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NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT (NPWTinDIEP)

Primary Purpose

Breast Cancer, Surgical Site Infection, Wound Dehiscence

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Negative Pressure Wound Therapy
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring DIEP, Negative Pressure Wound Therapy, Breast Reconstruction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Negative Pressure Wound Therapy

Standard Dressing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
The rate of wound dehiscence
The diagnosis of wound dehiscence will be made by clinical exam.

Full Information

First Posted
April 13, 2022
Last Updated
April 15, 2023
Sponsor
Western University, Canada
Collaborators
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05338281
Brief Title
NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT
Acronym
NPWTinDIEP
Official Title
Negative Pressure Wound Therapy for Abdominal Incisions in DIEP Reconstructions: A RCT
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study details changed, new Trial Registration process begun for modified protocol
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada
Collaborators
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Surgical Site Infection, Wound Dehiscence
Keywords
DIEP, Negative Pressure Wound Therapy, Breast Reconstruction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Negative Pressure Wound Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Dressing
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Negative Pressure Wound Therapy
Other Intervention Name(s)
Prevena™ Incision Management System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative Surgical Site Infection (SSI)
Description
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
Time Frame
30 days after operation
Secondary Outcome Measure Information:
Title
The rate of seroma diagnosis
Description
The diagnosis of seroma will be completed by clinical exam and/or diagnostic imaging such as ultrasound or computed tomography.
Time Frame
30 days after operation
Title
The rate of hematoma diagnosis
Description
The diagnosis of hematoma will be completed by clinical exam and/or diagnostic imaging such as ultrasound or computed tomography.
Time Frame
30 days after operation
Title
The rate of wound dehiscence
Description
The diagnosis of wound dehiscence will be made by clinical exam.
Time Frame
30 days after operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanya DeLyzer, MD, FRCSC
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT

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