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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Mammoplasty Patient; Malignant Breast Neoplasm; Obesity; Body Mass Index Greater Than or Equal to 30

Treatments: Procedure: Wound Care Management; Procedure: Negative Pressure Wound Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04003038

P30CA016672 (U.S. NIH Grant/Contract)

2018-0004 (Other Identifier)

NCI-2019-02777 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Group I (wound care with a standard dressing)

Active Comparator group

Description:

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

Treatment:

Procedure: Wound Care Management

Group II (NPWT)

Experimental group

Description:

Patients receive NPWT after surgery for 7 days.

Treatment:

Procedure: Negative Pressure Wound Therapy