prophylactic Vacuum-Assisted Closure on Perineal wound after Abdominoperineal resection for rectal Cancer

JRCT ID: jRCT1052240247

Registered date:22/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Malignant rectal tumor
• Date of first enrollment: 22/01/2025
• Target sample size: 50
• Study type: Interventional
• Intervention(s): pNPWT using Prevena after primary suture closure of a perineal wound after APR for 1 week.

Outcome(s)

• Primary Outcome: Incidence rate of SSI for the perineal wound within 30 days after surgery

Secondary Outcome

Postoperative complications other than the perineal wound SSI
Postoperative hospital stay
Completion rate of pNPWT

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients undergoing abdominoperineal resection for malignant rectal tumor
2) Meet the insurance requirements for the PREVENA incision management system (undergoing preoperative treatment (Neoadjuvant chemotherapy: NAC, Neoadjuvant chemoradiotherapy: NACRT, Total neoadjuvant therapy: TNT), BMI is 30 or more, hemoglobin A1c is 7.0% or more in NGSP, receiving steroid therapy, chronic maintenance dialysis, and/or malnutrition)
3) 18 years old and over, both sex, ECOG-PS is 0 or 1
4) Written consent to participate in this study

Exclude criteria

1) Emergency surgery cases
2) Cases where primary wound closure is undesirable because of obviously contaminated/infected wound
3) Myocutaneous flap reconstruction cases
4) Cases with allergies or hypersensitivity to silver or acrylic adhesives
5) Others

Related Information

• Primary Sponsor: Obama Kazutaka