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

Not Applicable

Recruiting

• Conditions: Malignant Breast Neoplasm; Mammoplasty Patient; Body Mass Index Greater Than or Equal to 30; Obesity
• Interventions: Procedure: Wound Care Management; Procedure: Negative Pressure Wound Therapy

• Registration Number: NCT04003038
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2019-05-02
• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-06-27
• Study First Posted: 2019-07-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (wound care with a standard dressing)	Wound Care Management	Patients receive wound care with a standard dressing (bandage) after surgery for 7 days.
Group II (NPWT)	Negative Pressure Wound Therapy	Patients receive NPWT after surgery for 7 days.

Primary Outcome Measures

Name	Time	Method
Wound healing complications	Up to 3 months	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.
Rate of wound dehiscence	Up to 3 months	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States