Clinical trial NCT05338281: NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT
Official title: Negative Pressure Wound Therapy for Abdominal Incisions in DIEP Reconstructions: A RCT
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Surgical Site Infection
Wound Dehiscence
Keywords: DIEP
Negative Pressure Wound Therapy
Breast Reconstruction
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
First posted: 2022-04-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 in a deep inferior epigastric perforator (DIEP) flap based reconstruction. Patients will be followed by 30 days post-operatively to compare outcomes including the rate of surgical site infection, seroma, and the scar quality.

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 reconstruction will be included in this study, and randomly divided into the two groups. Those with contraindications to ciNPT will be excluded. The surgical consultation and procedure will be conducted same for both groups. Patients will be followed by 30 days post-operatively. Outcome measures will include incidence of surgical site infection, wound dehiscence, seroma, hematoma, delayed wound healing, and surgical scar quality.

Eligibility criteria: Inclusion Criteria:

* Patients who are undergoing either immediate, or delayed reconstruction of the breast following mastectomy
* Patients going either unilateral or bilateral reconstruction

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Postoperative Surgical Site Infection (SSI)
timeFrame: 30 days after operation
Secondary outcomes:
measure: The rate of seroma diagnosis
timeFrame: 30 days after operation
measure: The rate of hematoma diagnosis
timeFrame: 30 days after operation
measure: The rate of wound dehiscence
timeFrame: 30 days after operation
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Tanya DeLyzer, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: