Barbed vs Non-Barbed Sutures for Emergency Abdominal Surgery

Overseen By Patrick K McGillen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Must not be taking: Immunosuppressants

Disqualifiers: Immune deficiencies, Nosocomial infections, Hernia, others

Compensation: Varies

Number of Visits: 30

Duration: Immediate postoperative period

250 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, if you are on chronic immunosuppressive medications, you would not be eligible to participate.

What data supports the effectiveness of using triclosan-coated barbed sutures for emergency abdominal surgery?

Research shows that triclosan-coated sutures can help reduce surgical site infections, which are common after abdominal surgeries. Barbed sutures help distribute tension evenly, which may improve blood flow and healing, suggesting they could be effective in emergency abdominal surgeries. ^{1 2 3 4 5}

Is it safe to use barbed and triclosan-coated sutures in emergency abdominal surgery?

Research shows that triclosan-coated sutures, including barbed ones, are generally safe and can help reduce the risk of surgical site infections (SSIs) in abdominal surgeries. These sutures are designed to improve wound healing by evenly distributing tension and enhancing blood supply to the wound edges. ^{1 2 5 6 7}

How do barbed and triclosan-coated sutures differ from other treatments for preventing infections in emergency abdominal surgery?

Barbed sutures distribute tension evenly, which can improve blood supply and healing, while triclosan-coated sutures have antibacterial properties that help reduce surgical site infections. This combination is unique because it addresses both mechanical and bacterial factors in wound healing, unlike traditional sutures that may not have these features. ^{1 2 3 6 8}

What is the purpose of this trial?

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.

Research Team

Matthew Martin, MD

Principal Investigator

Los Angeles General Medical Center

Eligibility Criteria

Adults aged 18+ needing emergency exploratory laparotomy for trauma or acute abdominal issues, who can have their abdomen fully closed during surgery. Excludes those with multiple surgeries planned, incarcerated individuals, preexisting connective tissue diseases or hernias, pregnant women, minors, immune deficiencies, chronic immunosuppression medication users, nosocomial infections or pre-existing hernia.

Inclusion Criteria

I am an adult who had emergency surgery through a midline cut and my deep cut was fully closed.

I have a surgical wound classified by the CDC.

Exclusion Criteria

You have a preexisting hernia in your abdomen.

I am under 18 years old.

I am on long-term medication to suppress my immune system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo emergency exploratory laparotomy with abdominal fascial closure using either triclosan-coated barbed suture or conventional non-barbed suture

Immediate postoperative period

Follow-up

Participants are monitored for surgical site infections, fascial dehiscence, and other outcomes

30 days

Regular follow-up visits until 30 days postoperatively

Extended Follow-up

Participants' hospital and ICU length of stay are monitored, along with any unplanned reoperations

90 days

Treatment Details

Interventions

• Conventional Non-Barbed Suture
• Triclosan-coated Barbed Suture

Trial Overview The trial is testing if triclosan-coated barbed sutures are better than conventional non-barbed sutures at preventing wound separation and infections after emergency abdominal surgery. Participants will be randomly assigned to one of the suture types and monitored for 30 days post-surgery.

Participant Groups

Group I: Triclosan-coated barbed suture group Active Control 1 Intervention

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.

Group II: Non-barbed suture group Placebo Group 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

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. [2021]

2. France pubmed.ncbi.nlm.nih.gov

Triclosan-coated sutures and surgical site infection in abdominal surgery: the TRISTAN review, meta-analysis and trial sequential analysis. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of triclosan-coated PDS Plus versus uncoated PDS II sutures for prevention of surgical site infection after abdominal wall closure: the randomised controlled PROUD trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of triclosan-coated sutures on the incidence of surgical site infection after abdominal wall closure in gastroenterological surgery: a double-blind, randomized controlled trial in a single center. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Triclosan-Coated Sutures Compared with Uncoated Sutures in Preventing Surgical Site Infection after Abdominal Wall Closure in Open/Laparoscopic Colorectal Surgery. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Do antibacterial skin sutures reduce surgical site infections after elective open abdominal surgery? - Study protocol of a prospective, randomized controlled single center trial. [2020]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Assessment of the effectiveness of the suture with triclosan coated in emergency surgery]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Surgical-site infection after abdominal wall closure with triclosan-impregnated polydioxanone sutures: results of a randomized clinical pathway facilitated trial (NCT00998907). [2022]