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Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery

Primary Purpose

Body Mass Index Greater Than or Equal to 30, Malignant Breast Neoplasm, Mammoplasty Patient

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Negative Pressure Wound Therapy
Wound Care Management
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Mass Index Greater Than or Equal to 30

Eligibility Criteria

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

Inclusion Criteria:

  • Patients undergoing a free abdominal flap, including a superficial inferior epigastric artery (SIEA), deep inferior epigastric artery perforator (DIEP), or muscle-sparing transverse rectus abdominus myocutaneous (MS-TRAM) flap for breast reconstruction.
  • Patients are willing and able to give consent.
  • Body mass index (BMI) greater than or equal to 30.0.

Exclusion Criteria:

  • Patients who are unable to provide consent.
  • Patients who are suspected or known to be pregnant.
  • Known allergy to topical adhesives.

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group I (wound care with a standard dressing)

Group II (NPWT)

Arm Description

Patients receive wound care with a standard dressing (bandage) after surgery for 7 days.

Patients receive NPWT after surgery for 7 days.

Outcomes

Primary Outcome Measures

Rate of wound dehiscence
Will measure and compare the wound healing outcomes of patients. All adverse events will be identified, graded for severity and assigned causality, reported to the required entities, and compiled for periodic review. After assigning causality, the principal investigator will decide the course of action for the study participant.
Wound healing complications
Will measure and compare the wound healing outcomes of patients. All adverse events will be identified, graded for severity and assigned causality, reported to the required entities, and compiled for periodic review. After assigning causality, the principal investigator will decide the course of action for the study participant.

Secondary Outcome Measures

Full Information

First Posted
June 27, 2019
Last Updated
October 2, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04003038
Brief Title
Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery
Official Title
A Randomized, Prospective Evaluation of Negative Pressure Wound Therapy on Abdominal Donor Site in Free Flap Breast Reconstruction in Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial studies the safety and how well negative pressure wound therapy works in healing the abdominal incision in obese patients undergoing free flap breast reconstruction surgery. Using negative pressure wound therapy (NPWT) instead of standard dressing (bandages) may improve wound healing at the surgical site in the abdomen where tissue was collected for breast reconstruction surgery.
Detailed Description
PRIMARY OBJECTIVES: I. Determine the impact of negative pressure wound therapy on wound healing as measured by wound dehiscence rate. II. Long-term follow-up on wound healing complications. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive wound care with a standard dressing (bandage) after surgery for 7 days. GROUP II: Patients receive negative pressure wound therapy (NPWT) after surgery for 7 days. After completion of study, patients are followed up at 2 weeks, and at 1 and 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Mass Index Greater Than or Equal to 30, Malignant Breast Neoplasm, Mammoplasty Patient, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (wound care with a standard dressing)
Arm Type
Active Comparator
Arm Description
Patients receive wound care with a standard dressing (bandage) after surgery for 7 days.
Arm Title
Group II (NPWT)
Arm Type
Experimental
Arm Description
Patients receive NPWT after surgery for 7 days.
Intervention Type
Procedure
Intervention Name(s)
Negative Pressure Wound Therapy
Other Intervention Name(s)
NPWT, Vacuum-Assisted Wound Closure
Intervention Description
Receive wound care with NPWT
Intervention Type
Procedure
Intervention Name(s)
Wound Care Management
Other Intervention Name(s)
Wound Care, Wound Care Treatment, Wound Management, Wound Treatment
Intervention Description
Receive wound care with a standard dressing (bandage)
Primary Outcome Measure Information:
Title
Rate of wound dehiscence
Description
Will measure and compare the wound healing outcomes of patients. All adverse events will be identified, graded for severity and assigned causality, reported to the required entities, and compiled for periodic review. After assigning causality, the principal investigator will decide the course of action for the study participant.
Time Frame
Up to 3 months
Title
Wound healing complications
Description
Will measure and compare the wound healing outcomes of patients. All adverse events will be identified, graded for severity and assigned causality, reported to the required entities, and compiled for periodic review. After assigning causality, the principal investigator will decide the course of action for the study participant.
Time Frame
Up to 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing a free abdominal flap, including a superficial inferior epigastric artery (SIEA), deep inferior epigastric artery perforator (DIEP), or muscle-sparing transverse rectus abdominus myocutaneous (MS-TRAM) flap for breast reconstruction. Patients are willing and able to give consent. Body mass index (BMI) greater than or equal to 30.0. Exclusion Criteria: Patients who are unable to provide consent. Patients who are suspected or known to be pregnant. Known allergy to topical adhesives.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edward H Chang
Phone
713-794-1247
Email
eichang@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward H Chang
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward I. Chang
Phone
713-794-1247
First Name & Middle Initial & Last Name & Degree
Edward I. Chang

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery

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