Barbed Suture vs Non-Barbed Closure for Emergency Exploratory Laparotomy RCT

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT06043414
Status
Not Yet Recruiting

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Conditions

  • Dehiscence Wound
  • Emergency General Surgery
  • Laparotomy
  • Surgical Site Infections
  • Trauma Abdomen

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • triclosan-coated barbed suture — DEVICE
    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 — DEVICE
    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 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Nov 2023
Primary completion
Sep 30, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Triclosan-coated barbed suture group
    The active arm of the study will including patients randomized to abdominal fascial closure with using triclosan-coated barbed (STRATAFIX™ Symmetric PDS™, Johnson \& Johnson) suture after emergency exploratory laparotomy.
  • Placebo Comparator: Non-barbed suture group
    The control arm of the study will including patients randomized to abdominal fascial closure with using non-barbed triclosan-coated suture(PDS™ Plus, Johnson \& Johnson) or non-coated polydioxanone (PDS™ II,Johnson \& Johnson) suture after emergency exploratory laparotomy.

Primary Outcome Measure

Wound Complication events [ Time Frame: 30 days postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Los Angeles General Medical CenterLos AngelesCalifornia90033
Matthew Martin, MD
[email protected]
Patrick K McGillen, MD
[email protected]

Find similar trials in Los Angeles, CA

By research site
Los Angeles General Medical Center· Los Angeles, CA

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