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HiSCO-15A study

A Multicenter Prospective Study on the Clinical Efficacy of Negative Pressure Wound Therapy for Perineal Wounds Following Abdominoperineal Resection

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1062260006
Enrollment
37
Registered
2026-04-09
Start date
2026-04-09
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

Rectal Cancer Abdominoperineal resection (APR)

Interventions

After abdominoperineal resection, the perineal wound is closed using a semi-closure technique. On postoperative day 1, a negative pressure wound therapy (NPWT) device is applied to the perineal wound.

Sponsors

Ohdan Hideki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients scheduled to undergo abdominoperineal resection (APR) for colorectal surgery. (2) Patients diagnosed with colorectal cancer histologically according to the "Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma (9th Edition)," who have received preoperative radiotherapy and are scheduled for Negative Pressure Wound Therapy (NPWT). (3)/(4) Patients aged 18 years or older who have provided written informed consent prior to study enrollment.

Exclusion criteria

Exclusion criteria: (1) Patients with contaminated perineal wounds accompanied by active infection. (2) Patients with known hypersensitivity to chemical substances (e.g., urethane, polyvinyl alcohol, acrylic adhesives). (3) Patients with comorbid psychiatric disorders that may interfere with the evaluation of the efficacy and safety of this study. (4) Other patients judged by the investigator or sub-investigator to be unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Incidence of perineal surgical site infection (SSI) within 30 days after surgery

Secondary

MeasureTime frame
1,Overall incidence of surgical site infection (SSI) 2,Incidence of SSI by anatomical site (Superficial, Deep, Organ/Space) 3,Length of hospital stay 4,Postoperative complications (Clavien-Dindo classification) 5,Causative pathogens of surgical site infection 6,Incidence of skin disorders associated with negative pressure wound therapy (NPWT)

Contacts

Public ContactManabu Shimomura

Hiroshima University Hospital

mshimo@hiroshima-u.ac.jp+81-82-257-5222

Outcome results

None listed

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