臨床研究等提出・公開システム

Date of registration	April. 16, 2023
Last modified on	April. 16, 2023
Trial ID	jRCT1032230026

Scientific Title	Incisional Negative Pressure Wound Therapy for Lower Intestinal Perforations
Public Title	Incisional Negative Pressure Wound Therapy for Lower Intestinal Perforations

Contact for Scientific Queries	Name	yuhei tsukazaki
	Affiliation	Department of Surgery
	Address	4-11-1 Izumihoncho, Komae, Tokyo, 201-8601, Japan.
	Telephone	+81-334801151
	E-mail	yuheeei0317@gmail.com
Contact for Public Queries	Name	yuhei tsukazaki
	Affiliation	Department of Surgery
	Address	4-11-1 Izumihoncho, Komae, Tokyo, 201-8601, Japan.
	Telephone	+81-334801151
	E-mail	yuheeei0317@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 16, 2023
Actual date of first enrollment		April. 01, 2020
Target sample size		40
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients with perforation of the lower gastrointestinal tract (cases of emergency surgery with open abdomen) 2) Age 20 years or older at the time of enrollment 3) Written consent to participate in the study has been obtained.
	Exclusion Criteria	1) Patients whose life is judged to be difficult to save 2) Patients who are judged by the principal investigator or subinvestigator to be ineligible for the study 3) Patients whose consent cannot be obtained in the informed consent document
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Lower intestinal Perforations
Intervention(s)		Patients were managed with the NPWT device and compared to a historical control group managed with standard postoperative dressings. The patients were placed on NPWT at a pressure of -120 mmHg for 5 days, starting immediately after surgery or the day after surgery, with the wound closed with subcutaneous implantable sutures using a 4-0 PDS. NPWT was applied for a total of 10 days in all patients.The RENASYS wound care system was used as the NPWT device.
Intervention(s) Keyword		perforation, SSI, NPWT
Primary Outcome(s)		Percentage of SSIs
Secondary Outcome(s)		Length of hospitalization Incidence of abdominal wall scar hernias

Name of Certified Review Board	Jikei University Clinical Research Review Committee
Address	Nishi-Shinbashi, Minato-ku,3-25-8, Tokyo
Telephone	+81-334331111
E-Mail	crb@jikei.ac.jp
Approval Status	Approval
Date of approval	April. 12, 2020

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none