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

ConditionsLaparotomyDehiscence WoundSurgical Site InfectionsTrauma AbdomenEmergency General Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Southern California

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Individuals under 18 years of age

Individuals with known immune deficiencies

Individuals taking chronic immunosuppressive medications

Individuals presenting with nosocomial infections

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Triclosan-coated barbed suture groupActive comparator 1 intervention
Group B: Non-barbed suture groupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Wound Complication events

Composite incidence of superficial surgical site infections and abdominal fascial dehiscence

Time frame
30 days postoperatively
2

Surgical Site Infection Incidence

Incidence of superficial surgical site infections

Time frame
30 days postoperatively
3

Fascial Dehiscence Incidence

Incidence of fascial dehiscence with or without evisceration of abdominal contents

Time frame
30 days postoperatively

Secondary outcomes

1

Hospital Length of Stay

Length of hospital stay in days

Time frame
90 days postoperatively
2

ICU Length of Stay

Length of intensive care admission in days

Time frame
90 days postoperatively
3

Incidence of Unplanned Reoperation

Incidence of unplanned reoperation for wound event

Time frame
30 days postoperatively
4

Incidence of Prolonged Postoperative Antibiotics

Incidence of administration of a prolonged antibiotic course (\>7 days) after fascial closure.

Time frame
30 days postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern California

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: