臨床研究等提出・公開システム

Date of registration	April. 09, 2026
Last modified on	May. 25, 2026
Trial ID	jRCT1062260006

Scientific Title	A Multicenter Prospective Study on the Clinical Efficacy of Negative Pressure Wound Therapy for Perineal Wounds Following Abdominoperineal Resection
Public Title	HiSCO-15A study

Contact for Scientific Queries	Name	Ohdan Hideki
	Affiliation	Hiroshima University Hospital
	Address	1-2-3 Kasumi, Minami-ku, Hiroshima city, Hiroshima JAPAN
	Telephone	+81-82-257-5222
	E-mail	hohdan@hiroshima-u.ac.jp
Contact for Public Queries	Name	Shimomura Manabu
	Affiliation	Hiroshima University Hospital
	Address	1-2-3 Kasumi, Minami-ku, Hiroshima city, Hiroshima JAPAN
	Telephone	+81-82-257-5222
	E-mail	mshimo@hiroshima-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 09, 2026
Target sample size		37
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	historical control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion 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	(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.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Rectal Cancer
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.
Health Condition(s) Keyword		Abdominoperineal resection (APR)
Intervention(s) Keyword		Negative pressure wound therapy (NPWT)
Primary Outcome(s)		Incidence of perineal surgical site infection (SSI) within 30 days after surgery
Secondary Outcome(s)		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)

Primary Sponsor

Source of Monetary Support	Hiroshima Surgical study group of Clinical Oncology
Secondary Sponsor	Not applicable

Name of Certified Review Board	Ethical Committee for Clinical Research of Hiroshima University
Address	Kasumi 1-2-3 Minami-Ku, Hiroshima, Hiroshima
Telephone	+81-82-257-1947
E-Mail	iryo-sinsa@office.hiroshima-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 31, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	May. 25, 2026	(this page)	Changes
1	April. 09, 2026	Detail

List of change history