Status:
WITHDRAWN
NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT
Lead Sponsor:
Western University, Canada
Collaborating Sponsors:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Breast Cancer
Surgical Site Infection
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
The current study is a single center randomized control trial that will examine the effect of closed incision negative pressure wound therapy (ciNPT) versus conventional dressing on abdominal incision...
Detailed Description
The current study will examine the effect of closed incision negative pressure wound therapy on DIEP flap donor site. A total of 520 patients who are candidates for DIEP flap-based breast reconstructi...
Eligibility Criteria
Inclusion
- Patients who are undergoing either immediate, or delayed reconstruction of the breast following mastectomy
- Patients going either unilateral or bilateral reconstruction
Exclusion
- Patients who are not candidates for DIEP flap based breast reconstruction, such as those with insufficient abdominal tissue, or unfit for the surgery will be excluded from this study. -
- Patients who have contraindications to the ciNPT
- Patients who have pre-existing conditions that may confound results such as bleeding disorder or therapeutic anticoagulation will be excluded from the study.
- Patients who do not want to carry an additional canister from the ciNPT during the initial recovery phase will be excluded from the study.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05338281
Start Date
September 1 2023
End Date
October 1 2025
Last Update
April 19 2023
Active Locations (1)
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1
London Health Sciences Centre
London, Ontario, Canada