NCT05338281

NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT

Negative Pressure Wound Therapy for Abdominal Incisions in DIEP Reconstructions: A RCT

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Western University, Canada · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Surgical Site Infection
• Wound Dehiscence

Interventions

Type	Name	Description
DEVICE	Negative Pressure Wound Therapy	The negative pressure wound therapy will be placed in addition to usual care of the abdominal donor site, such as closure with resorbable sutures, drain placements.

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-08-01
• Completion: 2025-10-01
• First posted: 2022-04-21
• Last updated: 2023-04-19

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study