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Negative Pressure Wound Therapy

Negative Pressure Wound Therapy for Breast Cancer (NPWTinDIEP Trial)

N/A
Waitlist Available
Led By Tanya DeLyzer, MD, FRCSC
Research Sponsored by Western University, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after operation
Awards & highlights

NPWTinDIEP Trial Summary

This trial will compare the effect of closed incision negative pressure wound therapy (ciNPT) to conventional dressing on abdominal incisions in DIEP flap based reconstruction.

Eligible Conditions
  • Breast Cancer
  • Wound Separation
  • Surgical Site Infection

NPWTinDIEP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after operation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Communicable Diseases
Secondary outcome measures
The rate of hematoma diagnosis
The rate of seroma diagnosis
The rate of wound dehiscence

NPWTinDIEP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Negative Pressure Wound TherapyExperimental Treatment1 Intervention
This group will receive the usual care of the abdominal donor wound following DIEP flap-based breast reconstruction surgery, AND the negative pressure wound therapy. The Prevena™ Incision Management System will be placed at the abdominal flap donor site after incision is closed. The Prevena™ will remain for up to 5 days, or until patient is discharged from the hospital.
Group II: Standard DressingActive Control1 Intervention
This group will receive the usual care of the abdominal donor wound following DIEP flap-based breast reconstruction surgery, and standard dressing which will be composed of gauze, secured with paper tape.
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?

Lawson Health Research InstituteOTHER
658 Previous Clinical Trials
413,658 Total Patients Enrolled
6 Trials studying Breast Cancer
260 Patients Enrolled for Breast Cancer
Western University, CanadaLead Sponsor
239 Previous Clinical Trials
57,483 Total Patients Enrolled
Tanya DeLyzer, MD, FRCSCPrincipal InvestigatorLondon Health Sciences Centre

Frequently Asked Questions

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

Are there any openings available for those interested in this trial?

"According to the details posted on clinicaltrials.gov, this research trial is not enrolling participants at present; it was initially advertised on September 1st 2022 and had its most recent update dated April 20th 2022. While current enrolment for this study is closed, there are other 1476 medical studies currently recruiting volunteers."

Answered by AI

Is this medical study open to minors?

"According to the rules of this medical trial, potential participants must be between 18-70 years old."

Answered by AI

What are the criteria for enrollment in this research project?

"Eligibility criteria for this trial requires prospective participants to have breast cancer and be in the 18-70 age range. A total of 520 people will be admitted overall."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
London Health Sciences Centre
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT
Tanya DeLyzer 2023. "NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05338281.
~0 spots leftby Aug 2025
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