Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04003038

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

A Randomized, Prospective Evaluation of Negative Pressure Wound Therapy on Abdominal Donor Site in Free Flap Breast Reconstruction in Obese Patients

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURENegative Pressure Wound TherapyReceive wound care with NPWT
PROCEDUREWound Care ManagementReceive wound care with a standard dressing (bandage)

Timeline

Start date
2019-05-02
Primary completion
2026-04-30
Completion
2026-04-30
First posted
2019-07-01
Last updated
2026-04-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04003038. Inclusion in this directory is not an endorsement.