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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights

Study 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.

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
2,973 Previous Clinical Trials
1,789,241 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,825 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the number of participants involved in this experiment?

"Affirmative. Clinicaltrials.gov records indicate that this experiment is actively enrolling patients since its posting on May 2nd, 2019 and last update on May 16th 2022. 80 individuals are necessary from a single medical centre for the study to be completed successfully."

Answered by AI

Is there an open enrollment period for participation in this research project?

"Affirmative, the clinical trial is still recruiting. According to information available on clinicaltrials.gov, this study first went live on May 2nd 2019 and was recently updated on May 16th 2022. With one site in operation, 80 participants are necessary for completion of the trial."

Answered by AI

Who else is applying?

What state do they live in?
Utah
Texas
How old are they?
18 - 65
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

To motivate my self. To help boost my confidence. I’m a domestic violence victim Im trying to learn how to love myself.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery
2019. "Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04003038.
All > Breast Cancer Houston > Obesity
~23 spots leftby Apr 2026
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