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Negative Pressure Wound Therapy for Breast Reconstruction in Obese Patients

N/A
Recruiting
Led By Edward H Chang
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be older than 18 years old
Must not have
Patients who are unable to provide consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights

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.

Who is the study for?
This trial is for obese patients with a BMI of 30 or higher who are undergoing free flap breast reconstruction surgery after breast cancer. They must be able to consent and not have allergies to topical adhesives. Pregnant individuals cannot participate.Check my eligibility
What is being tested?
The study is testing if Negative Pressure Wound Therapy (NPWT) can better heal abdominal incisions compared to standard wound care in obese patients having tissue moved for breast reconstruction.See study design
What are the potential side effects?
Possible side effects may include skin irritation, discomfort at the treatment site, or an allergic reaction to the NPWT materials used on the wound.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having a specific type of breast reconstruction using tissue from my abdomen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to give consent by myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of wound dehiscence
Wound healing complications

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (NPWT)Experimental Treatment1 Intervention
Patients receive NPWT after surgery for 7 days.
Group II: Group I (wound care with a standard dressing)Active Control1 Intervention
Patients receive wound care with a standard dressing (bandage) after surgery for 7 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Negative Pressure Wound Therapy
2019
N/A
~4690

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,199 Total Patients Enrolled
148 Trials studying Breast Cancer
63,277 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,321 Total Patients Enrolled
944 Trials studying Breast Cancer
1,544,008 Patients Enrolled for Breast Cancer
Edward H ChangPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Negative Pressure Wound Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04003038 — N/A
Breast Cancer Research Study Groups: Group II (NPWT), Group I (wound care with a standard dressing)
Breast Cancer Clinical Trial 2023: Negative Pressure Wound Therapy Highlights & Side Effects. Trial Name: NCT04003038 — N/A
Negative Pressure Wound Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04003038 — N/A
Breast Cancer Patient Testimony for trial: Trial Name: NCT04003038 — N/A
~20 spots leftby Apr 2026