Barbed Suture vs Non-Barbed Closure for Emergency Exploratory Laparotomy RCT
NCT ID: NCT06043414
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
250 participants
INTERVENTIONAL
2024-01-01
2027-01-31
Brief Summary
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Detailed Description
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The study aims to build upon previous research that has shown the potential benefits of triclosan-coated barbed suture in abdominal wall closure. A randomized controlled trial conducted by Llavero et al. in 2015 demonstrated a reduction in SSI rates when using non-barbed triclosan-coated suture for abdominal wall closure in patients undergoing open surgery for fecal peritonitis. Another prospective, randomized multicenter trial conducted by Garcia-Marin et al. in 2020 showed that triclosan-coated barbed suture (STRATAFIX™ Symmetric PDS™, Johnson \& Johnson) used for closure of the abdominal fascia after emergent midline laparotomy reduced the incidence of SSI and acute evisceration compared to standard fascial closure techniques using triclosan-coated polydioxanone suture (PDS™ Plus, Johnson \& Johnson) and non-coated polydioxanone (PDS™, Johnson \& Johnson) suture. However, these studies focused on specific patient populations, and their findings may not be directly generalizable to patients with traumatic injuries or emergent general surgical conditions in the United States, which highlights the need for further investigation.
The primary objective of this study is to evaluate the effectiveness of triclosan-coated barbed suture compared to conventional non-barbed suture in reducing the rates of incisional SSI and fascial dehiscence (FD) within 30 days after abdominal fascial closure following emergency exploratory laparotomy. The study population will consist of adult patients presenting to Los Angeles General Medical Center who require emergent laparotomy for traumatic injuries or acute intraabdominal pathology. The study will employ a prospective, single-blinded randomized control trial methodology, with Los Angeles General Medical Center serving as the sole participating site.
Eligible patients will be randomly assigned to either the treatment group receiving triclosan-coated barbed suture or the control group receiving conventional non-barbed suture for abdominal fascial closure. The closure technique for both groups will follow standard practice guidelines, including a 4:1 length of suture to wound ratio with small bites of tissue less than 1 cm from the fascial edge.
Postoperatively, patients will be closely monitored for the occurrence of surgical site infections, fascial dehiscence, and other predefined outcomes of interest. This monitoring will continue for 30 days or until discharge, whichever comes first. Comprehensive data, including patient demographics, clinical characteristics, surgical details, and outcomes, will be collected from electronic medical records and other relevant sources.
The collected data will undergo rigorous statistical analysis to compare the outcomes between the treatment and control groups. Appropriate statistical tests will be employed to evaluate the effectiveness of triclosan-coated barbed suture in reducing the incidence of incisional SSI and fascial dehiscence, along with assessing secondary outcomes and patient-centered endpoints.
The study will adhere to ethical considerations, ensuring patient confidentiality and privacy. Approval from the Institutional Review Board (IRB) will be obtained, and the study will comply with all applicable regulations and guidelines. Informed consent for participation in the study will be obtained from the patient or a legal authorized representative.
The findings of this study have the potential to enhance evidence-based practices and aid surgical decision-making in emergency settings. By comparing the efficacy of triclosan-coated barbed suture and conventional non-barbed suture, the study aims to provide valuable insights into reducing the rates of incisional SSI and fascial dehiscence, ultimately improving patient outcomes and reducing healthcare costs associated with these complications.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Individuals with CDC Class I, II, III and IV type surgical wounds
Exclusion Criteria
* 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.
18 Years
100 Years
ALL
No
Sponsors
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University of Southern California
OTHER
Responsible Party
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Matthew Martin
Professor of Surgery, Director of Acute Care Surgery Research
Principal Investigators
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Matthew Martin, MD
Role: PRINCIPAL_INVESTIGATOR
Los Angeles General Medical Center
Locations
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Los Angeles General Medical Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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APP-23-03323
Identifier Type: -
Identifier Source: org_study_id