Negative Pressure Wound Therapy for Abdominal Incisions in DIEP Reconstructions: A RCT
| Registry | NCT05338281, acronym NPWTinDIEP |
|---|---|
| Status | Withdrawn - Study details changed, new Trial Registration process begun for modified protocol |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, prevention |
| Sponsor | Western University, Canada (Other); collaborators: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Conditions | Breast Cancer, Surgical Site Infection, Wound Dehiscence |
| Interventions | Negative Pressure Wound Therapy (Device) |
| Dates | start 2023-09-01 (estimated), primary completion 2025-08-01 (estimated), completion 2025-10-01 (estimated), first posted 2022-04-21, last updated 2023-04-19 |
| Locations | 1 site in Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for Breast Cancer All trials for Surgical Site Infection All trials of Negative Pressure Wound Therapy
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Device: Negative Pressure Wound Therapy | 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. |
| Standard Dressing | Active comparator | Device: Negative Pressure Wound Therapy | 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. |
Sex: Female, ages: 18 Years to 70 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| London Health Sciences Centre | London, Ontario | Canada |