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

NCT06043414 | Not Yet Recruiting FDA Device

• 1 other identifier: APP-23-03323
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

fascial dehiscence; surgical site infection; laparotomy; ex-lap; STRATAFIX; PDS; triclosan-coated barbed suture

Outcome Measures

Primary Outcomes (3)

• Wound Complication events

  Composite incidence of superficial surgical site infections and abdominal fascial dehiscence

  30 days postoperatively

• Surgical Site Infection Incidence

  Incidence of superficial surgical site infections

  30 days postoperatively

• Fascial Dehiscence Incidence

  Incidence of fascial dehiscence with or without evisceration of abdominal contents

  30 days postoperatively

Secondary Outcomes (4)

• Hospital Length of Stay

  90 days postoperatively

• ICU Length of Stay

  90 days postoperatively

• Incidence of Unplanned Reoperation

  30 days postoperatively

• Incidence of Prolonged Postoperative Antibiotics

  30 days postoperatively

Study Arms (2)

Triclosan-coated barbed suture group

ACTIVE COMPARATOR

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.

Device: triclosan-coated barbed suture

Non-barbed suture group

PLACEBO COMPARATOR

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.

Device: triclosan-coated non-barbed suture; Device: Non-coated non-barbed suture

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.

Also known as: STRATAFIX™ Symmetric PDS™

Triclosan-coated barbed suture group

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.

Also known as: PDS™ Plus

Non-barbed suture group

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.

Also known as: PDS™ II

Non-barbed suture group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult individuals aged 18 years or older who undergo emergent laparotomy via a midline approach for trauma or non-trauma emergency general surgery who undergo complete fascial closure at the time of the index laparotomy operation.
• Individuals with CDC Class I, II, III and IV type surgical wounds

You may not qualify if:

• Individuals under 18 years of age
• Individuals with known immune deficiencies
• Individuals taking chronic immunosuppressive medications
• Individuals presenting with nosocomial infections
• Individuals presenting with pre-existing abdominal wall hernia
• Individuals requiring multiple operations for sequential fascial closure
• Individuals incarcerated at time of operation
• Individuals with known preexisting connective tissue disease
• Individuals with known preexisting ventral abdominal wall hernia
• Individuals who are pregnant time of operation
• Individuals who are deceased prior to conclusion of exploratory laparotomy
• Individuals lost to follow-up or deceased during the first 30 days after laparotomy.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Location

Related Publications (7)

• Ruiz-Tovar J, Llavero C, Jimenez-Fuertes M, Duran M, Perez-Lopez M, Garcia-Marin A. Incisional Surgical Site Infection after Abdominal Fascial Closure with Triclosan-Coated Barbed Suture vs Triclosan-Coated Polydioxanone Loop Suture vs Polydioxanone Loop Suture in Emergent Abdominal Surgery: A Randomized Clinical Trial. J Am Coll Surg. 2020 May;230(5):766-774. doi: 10.1016/j.jamcollsurg.2020.02.031. Epub 2020 Feb 27.

  PMID: 32113031 BACKGROUND

• Ruiz-Tovar J, Alonso N, Morales V, Llavero C. Association between Triclosan-Coated Sutures for Abdominal Wall Closure and Incisional Surgical Site Infection after Open Surgery in Patients Presenting with Fecal Peritonitis: A Randomized Clinical Trial. Surg Infect (Larchmt). 2015 Oct;16(5):588-94. doi: 10.1089/sur.2014.072. Epub 2015 Jul 14.

  PMID: 26171624 BACKGROUND

• Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96.

  PMID: 10196487 BACKGROUND

• Walming S, Angenete E, Block M, Bock D, Gessler B, Haglind E. Retrospective review of risk factors for surgical wound dehiscence and incisional hernia. BMC Surg. 2017 Feb 22;17(1):19. doi: 10.1186/s12893-017-0207-0.

  PMID: 28222776 BACKGROUND

• Millbourn D, Cengiz Y, Israelsson LA. Effect of stitch length on wound complications after closure of midline incisions: a randomized controlled trial. Arch Surg. 2009 Nov;144(11):1056-9. doi: 10.1001/archsurg.2009.189.

  PMID: 19917943 BACKGROUND

• Patel SV, Paskar DD, Nelson RL, Vedula SS, Steele SR. Closure methods for laparotomy incisions for preventing incisional hernias and other wound complications. Cochrane Database Syst Rev. 2017 Nov 3;11(11):CD005661. doi: 10.1002/14651858.CD005661.pub2.

  PMID: 29099149 BACKGROUND

• de Jonge SW, Atema JJ, Solomkin JS, Boermeester MA. Meta-analysis and trial sequential analysis of triclosan-coated sutures for the prevention of surgical-site infection. Br J Surg. 2017 Jan;104(2):e118-e133. doi: 10.1002/bjs.10445. Epub 2017 Jan 17.

  PMID: 28093723 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection; Abdominal Injuries

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Matthew Martin, MD

  Los Angeles General Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Martin, MD

CONTACT

323-409-8597; matthew.martin@med.usc.edu

Patrick K McGillen, MD

CONTACT

323-409-8597; patrick.mcgillen@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The operative team will be blinded to the assigned treatment group until the patient's edibility is confirmed immediately prior to abdominal fascial closure. Once eligibility is confirmed the surgical team will be unblinded in order to proceed with abdominal fascia closure according to the assigned treatment group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Director of Acute Care Surgery Research

Model Details: This is a two-arm prospective, single-blinded randomized control trial for clinical research.

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)