Clinical Research Directory
Browse clinical research sites, groups, and studies.
Barbed Suture vs Non-Barbed Closure for Emergency Exploratory Laparotomy RCT
Sponsor: University of Southern California
Summary
This randomized control trial aims to compare the efficacy of triclosan-coated barbed suture (TCB) versus conventional non-barbed polydioxanone (PDS) suture in the closure of the abdominal fascia after emergency exploratory laparotomy. The study addresses the common complications of incisional surgical site infections (SSI) and fascial dehiscence (FD) following emergency exploratory laparotomy. The primary objective is to assess the effectiveness of triclosan-coated barbed suture and conventional non-barbed suture in reducing the rates of incisional SSI and FD within 30 days postoperatively. The study population comprises adult patients undergoing emergent laparotomy for traumatic injuries or acute intraabdominal pathology. This prospective, single-blinded randomized control trial will be conducted at Los Angeles General Medical Center. Patients will be randomized to receive either triclosan-coated barbed suture or conventional non-barbed suture for abdominal fascial closure, with a standard closure technique employed. Patients will be followed up for 30 days postoperatively to monitor surgical site infections, fascial dehiscence, and other outcomes. Statistical analysis will be conducted to compare outcomes between the study arms, assessing the efficacy of triclosan-coated barbed suture in reducing the incidence of SSI and FD, along with secondary outcomes.
Official title: Incisional Surgical Site Infection and Fascial Dehiscence After Abdominal Fascial Closure With Triclosan-Coated Barbed Suture vs Polydioxanone Suture After Emergency Exploratory Laparotomy: A Randomized Control Trial
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2024-01-01
Completion Date
2027-01-31
Last Updated
2023-11-28
Healthy Volunteers
No
Interventions
triclosan-coated barbed suture
STRATAFIX™ Symmetric PDS™ (Johnson \& Johnson) triclosan-coated polydioxanone barbed suture caliber 0 or 1 will be the standardized suture used for abdominal fascial closure in patients randomized to the treatment group. STRATAFIX™ Symmetric PDS™ is an FDA approved sterile, synthetic, absorbable, barbed triclosan-coated polydioxanone suture. Its indications for use include soft tissue approximation where absorbable suture is appropriate.
triclosan-coated non-barbed suture
PDS™ Plus (Johnson \& Johnson) non-barbed triclosan-coated polydioxanone suture in either 0 or 1 caliber will be used for abdominal fascial closure in patients randomized to the control group. PDS™ Plus is an FDA approved sterile, synthetic, absorbable, triclosan-coated surgical monofilament suture prepared from the polyester, poly(p-dioxanone). Its indications for use include soft tissue approximation where absorbable suture is appropriate.
Non-coated non-barbed suture
PDS™ II (Johnson \& Johnson) non-barbed non-coated polydioxanone suture in either 0 or 1 caliber will be used for abdominal fascial closure in patients randomized to the control group. PDS™ II is a FDA approved sterile, synthetic, absorbable, surgical monofilament suture prepared from the polyester, polyester, poly(p-dioxanone) indicated for use in soft tissue approximation where absorbable suture is appropriate.
Locations (1)
Los Angeles General Medical Center
Los Angeles, California, United States