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

Laparotomy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06043414
• Other study ID #: APP-23-03323
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 31, 2027

Study information

• Verified date: November 2023
• Source: University of Southern California
• Contact: Matthew Martin, MD
• Phone: 323-409-8597
• Email: matthew.martin[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The proposed study is a randomized control trial that aims to compare the efficacy of triclosan-coated barbed suture versus conventional non-barbed polydioxanone (PDS) suture in the closure of the abdominal fascia after emergency exploratory laparotomy. Triclosan-coated barbed suture (STRATAFIX™ Symmetric, Johnson & Johnson) is a knotless type of surgical suture that has gained popularity due to its unique features. It is coated with an antiseptic material and has barbs that lock into position when placed through soft tissue, such as the abdominal fascia. Unlike conventional monofilament suture material, barbed sutures distribute tension evenly throughout the reapproximated opposing fascial edges, reducing local ischemia, which is a risk factor for poor wound healing and surgical site infections (SSI). Additionally, the use of barbed sutures eliminates the need for traditional suture knots and relies less on a surgeon's knot-tying ability. Triclosan, the antiseptic material coating the suture, inhibits bacterial growth and has been shown to reduce bacterial colonization of sutures for at least seven days in vitro. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: January 31, 2027
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Abdominal Injuries
• Emergencies
• Emergency General Surgery
• Infections
• Laparotomy
• Surgical Site Infections
• Surgical Wound Infection
• Trauma Abdomen

Intervention

Device:
• 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

Country	Name	City	State
United States	Los Angeles General Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Complication events	Composite incidence of superficial surgical site infections and abdominal fascial dehiscence	30 days postoperatively
Primary	Surgical Site Infection Incidence	Incidence of superficial surgical site infections	30 days postoperatively
Primary	Fascial Dehiscence Incidence	Incidence of fascial dehiscence with or without evisceration of abdominal contents	30 days postoperatively
Secondary	Hospital Length of Stay	Length of hospital stay in days	90 days postoperatively
Secondary	ICU Length of Stay	Length of intensive care admission in days	90 days postoperatively
Secondary	Incidence of Unplanned Reoperation	Incidence of unplanned reoperation for wound event	30 days postoperatively
Secondary	Incidence of Prolonged Postoperative Antibiotics	Incidence of administration of a prolonged antibiotic course (>7 days) after fascial closure.	30 days postoperatively