NIPH Clinical Trials Search

A study comparing two suture methods to reduce wound complications after hepatobiliary and pancreatic surgery

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Hepatobiliary and pancreatic cancers and related diseases
Date of first enrollment	22/08/2025
Target sample size	240
Countries of recruitment
Study type	Interventional
Intervention(s)	The intervention in this study is a comparison of suture methods used for wound closure after hepatobiliary and pancreatic surgery (hepatectomy or pancreatectomy). Specifically, it compares skin and subcutaneous closure with Stratafix absorbable barbed suture versus conventional closure with PDS absorbable monofilament suture, in order to evaluate their impact on postoperative wound complications.

Outcome(s)

Primary Outcome	The primary outcome is the incidence of incisional hernia within one year after surgery.
Secondary Outcome	Incidence of surgical site infection (SSI) Incidence of wound dehiscence Incidence of other wound-related complications, such as subcutaneous abscess Incidence of postoperative complications within 30 and 90 days, classified by the Clavien-Dindo system

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender
Include criteria	Individuals aged 18 years or older at the time of obtaining informed consent. Patients scheduled to undergo open hepatobiliary surgery (hepatectomy or pancreatectomy) at the Department of Gastroenterological, Transplant, and Pediatric Surgery, Shinshu University School of Medicine, or at participating collaborating institutions. Surgical cases in which either Stratafix or PDS can be used for skin and subcutaneous closure of the wound. Patients who are able to undergo postoperative follow-up for one year via outpatient visits or telephone contact. Individuals who have received sufficient explanation regarding the purpose and details of this study, and who have provided written informed consent voluntarily.
Exclude criteria	Patients with obvious infection at the surgical wound or surrounding tissue (including contaminated wounds or necrotic wounds). Patients receiving systemic immunosuppressive therapy or in a state of severe immunosuppression (e.g., long-term steroid use, ongoing chemotherapy). Cases requiring artificial reinforcement materials (such as mesh) or special auxiliary sutures for wound closure. Patients with a previous laparotomy that would result in the same abdominal incision site. Patients with a history of allergy to PDS or triclosan. Pregnant or possibly pregnant women, and women who are breastfeeding. Patients judged to lack the capacity to provide informed consent (e.g., those with severe dementia or psychiatric disorders). Patients from whom appropriate written informed consent could not be obtained at the time of enrollment. Any other patients deemed inappropriate for inclusion in this study by the principal investigator.