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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04003038
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 2, 2019
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Group I (wound care with a standard dressing)
    Patients receive wound care with a standard dressing (bandage) after surgery for 7 days.
  • Experimental: Group II (NPWT)
    Patients receive NPWT after surgery for 7 days.

Primary Outcome Measure

Rate of wound dehiscence [ Time Frame: Up to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Edward I. Chang
713-794-1247
Edward I. Chang (PRINCIPAL_INVESTIGATOR)

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