Back to Trials
NCT04003038NARecruiting

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

M.D. Anderson Cancer Center

Start Date

5/2/2019

Completion Date

4/30/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

PROCEDURE

Negative Pressure Wound Therapy

PROCEDURE

Wound Care Management

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Body Mass Index Greater Than or Equal to 30Malignant Breast NeoplasmMammoplasty PatientObesity

Locations

M D Anderson Cancer Center

Houston, Texas 77030

United States