NIPH Clinical Trials Search

HiSCO-15A study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Rectal Cancer
Date of first enrollment	09/04/2026
Target sample size	37
Countries of recruitment
Study type	Interventional
Intervention(s)	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. A dressing material is applied to the wound, and negative pressure is initiated.

Outcome(s)

Primary Outcome	Incidence of perineal surgical site infection (SSI) within 30 days after surgery
Secondary Outcome	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)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.