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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1052240247
Enrollment
50
Registered
2025-01-22
Start date
2025-02-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant rectal tumor Malignant rectal tumor

Interventions

pNPWT using Prevena after primary suture closure of a perineal wound after APR for 1 week.
Primary Prevention
prophylactic negative pressure wound therapy, pNPWT

Sponsors

Obama Kazutaka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Incidence rate of SSI for the perineal wound within 30 days after surgery

Secondary

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

Contacts

Public ContactTakuya Takami

Kyoto University Graduate School of Medicine

t_takami@kuhp.kyoto-u.ac.jp+81-75-366-7595

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026