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

Obesity Clinical Trial

Official title:

A Randomized, Prospective Evaluation of Negative Pressure Wound Therapy on Abdominal Donor Site in Free Flap Breast Reconstruction in Obese Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04003038
• Other study ID #: 2018-0004
• Secondary ID: NCI-2019-0277720
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2019
• Est. completion date: April 30, 2026

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Edward H Chang
• Phone: 713-794-1247
• Email: eichang[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Mass Index Greater Than or Equal to 30
• Breast Neoplasms
• Malignant Breast Neoplasm
• Mammoplasty Patient
• Obesity

Intervention

Procedure:
• Negative Pressure Wound Therapy
Receive wound care with NPWT
• Wound Care Management
Receive wound care with a standard dressing (bandage)

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 3 months
Primary	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.	Up to 3 months

External Links

•   MD Anderson Cancer Center Website