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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients who are unable to provide consent.

Patients who are suspected or known to be pregnant.

Known allergy to topical adhesives.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Negative Pressure Wound Therapy

    Procedure/Surgery

    Receive wound care with NPWT

  • Wound Care Management

    Procedure/Surgery

    Receive wound care with a standard dressing (bandage)

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group I (wound care with a standard dressing)Active comparator 1 intervention
Group B: Group II (NPWT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 3 months
2

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.

Time frame
Up to 3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator