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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of stitches used in emergency abdominal surgeries to determine which one better prevents complications. One type is a special barbed suture with triclosan, which may help fight infection, while the other is a conventional non-barbed suture. The goal is to identify which suture more effectively reduces infections and maintains proper wound closure after surgery. The trial seeks adults who have undergone emergency abdominal surgery due to trauma or sudden illness. Researchers will monitor participants for a month to check for issues like infections or wound reopening. As an unphased trial, this study allows participants to contribute to important research that could improve surgical outcomes for future patients.

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 prior data suggests that these sutures are safe for emergency abdominal surgery?

Research has shown that triclosan-coated barbed sutures are generally safe for patients. One study found that these sutures reduced the risk of infections after abdominal surgeries. Another study demonstrated that patients who underwent hernia repairs with these sutures healed as well as those with other sutures. Barbed sutures effectively close wounds with good results. These studies suggest that the sutures are well-tolerated and do not pose major safety concerns.

Triclosan-coated sutures have been used in other surgeries, supporting their safety. While all medical treatments carry some risks, current evidence indicates that triclosan-coated barbed sutures are generally safe for use in surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it's exploring whether triclosan-coated barbed sutures can offer better outcomes in emergency abdominal surgeries compared to conventional non-barbed sutures. Unlike standard sutures, barbed sutures feature tiny barbs that help them stay in place without the need for knots, potentially reducing surgery time and improving healing. Additionally, the triclosan coating may reduce the risk of infection, a major concern in surgical procedures. By comparing these two approaches, the study aims to determine if barbed sutures can enhance recovery and lower complication rates in patients undergoing emergency exploratory laparotomy.

What evidence suggests that this trial's treatments could be effective for reducing surgical site infections and fascial dehiscence?

This trial will compare triclosan-coated barbed sutures with conventional non-barbed sutures for emergency abdominal surgery. Research has shown that triclosan-coated barbed stitches can lower the risk of infections and wound reopening after surgery. These stitches have been linked to fewer healing problems following emergency abdominal surgeries. Triclosan, a bacteria-fighting substance, helps reduce infection rates, while the barbed design keeps the wound closed. Traditional stitches without barbs have also proven effective, but they might not offer the same benefits in preventing infections and wound reopening. Both types of stitches are commonly used, but triclosan-coated barbed ones may lead to better results in some cases. Participants in this trial will be randomized to receive either triclosan-coated barbed sutures or conventional non-barbed sutures. ^{1 2 3 6 7}

Who Is on the Research Team?

Matthew Martin, MD

Principal Investigator

Los Angeles General Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11297053/

Clinical outcomes of triclosan-coated barbed suture in ... This study showed that patients who underwent open hernia repair appeared to recover equally well regardless of the suture type.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11894428/

Clinical Outcomes Among Patients Undergoing Open ... Is barbed better? Evaluation of triclosan-coated barbed suture on wound complications following emergency laparotomy. J Trauma Acute Care ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S107275152030212X

Incisional Surgical Site Infection after Abdominal Fascial ... The results of this study indicated that triclosan-coated sutures reduce the risk of incisional SSI, whereas barbed sutures reduce the risk of postoperative ...

4. ctv.veeva.com ctv.veeva.com/study/barbed-suture-vs-non-barbed-closure-for-emergency-exploratory-laparotomy-rct

Barbed Suture vs Non-Barbed Closure for Emergency ... This randomized control trial aims to compare the efficacy of triclosan-coated barbed suture (TCB) versus conventional non-barbed ...

5. researchgate.net researchgate.net/publication/379725573_Is_Barbed_Better_Evaluation_of_Triclosan-Coated_Barbed_Suture_on_Wound_Complications_Following_Emergency_Laparotomy

Is Barbed Better? Evaluation of Triclosan-Coated ... Moreover, triclosan-coated barbed sutures were independently associated with decreased fascial dehiscence rates after emergency laparotomy [36] . According to ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03763279

Effect of Barbed Suture and Triclosan-coated Monofilament ... Group 2:Abdominal fascial closure will be performed with Triclosan-coated Polydioxanone loop suture (PDS plus looc, J&J), caliber 1, 48mm-cylindric needle.

7. pdfs.semanticscholar.org pdfs.semanticscholar.org/a0b8/2f49d0b9a64af70f911f4366b1cf877ba3e7.pdf

Evaluation of Wound Closure Outcomes Using Barbed ... Interpretation and conclusion: Barbed delayed absorbable suture can be used for emergency laparotomy wound closure with satisfactory outcomes.