Multicenter Prospective Randomized Trial about Clinical Effect of Absorbable Suture Materials against Surgical Site Infection in Hepatic Resection and Pancreatoduodenectomy

UMIN ID: UMIN000001545

Registered date:01/01/2009

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Liver disease, Pancreas disease
• Date of first enrollment: 2009/01/01
• Target sample size: 610
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Use of silk sutures in peritoneal cavity
Use of absorbable sutures in peritoneal cavity

Outcome(s)

• Primary Outcome: Rate of surgical site infection occurrence
• Secondary Outcome: 1) Rate of surgical site infection occurrence by sites (superficial incision wound, deep incision wound, organ/cavity) 2) 1. Duration until healing of surgical site infection 2. Occurrence rate in pancreas leakage or bile leakage 3. Hospital stay after surgery

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) Emergency cases 2) Group 1: Biliary reconstruction in hepatic resection Group 2: Concomitant hepatic resection in pancreatoduodenectomy 3) Active infection 4) Pregnancy 5) ASA physical status 3< 6) Preoperative chemotherapy, radiotherapy, use of antibiotics within 2 weeks, use of immunosuppressive agent 7) Uncontrolled diabetes mellitus 8) Severe organ failure 9) Present stoma 10) Not eligible judged by doctor

Related Information

• Primary Sponsor: Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare