Effect of Barbed Suture and Triclosan-coated Monofilament in Emergency Surgery

Suture of the Abdominal Wall With Triclosan-coated Polydioxanone Barbed Suture vs Triclosan-coated Polydioxanone Monofilament vs Polydioxanone Monofilament in Emergency Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03763279

Enrollment

150

Registered

2018-12-04

Start date

2018-11-30

Completion date

2019-03-31

Last updated

2019-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

Brief summary

Patients will be randomized 3 groups: Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed Polydioxanone suture Group 2:Abdominal fascial closure will be performed with Triclosan-coated monofilament Polydioxanone suture Group 3: Abdominal fascial closure will be performed with monofilament Polydioxanone suture Incisional surgical.site infection and evisceration will be recorded.

Detailed description

Patients will be randomized 3 groups: Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed Polydioxanone suture (Stratafix Symmetric, J&J), caliber 1, 48mm-cylindric needle. Group 2:Abdominal fascial closure will be performed with Triclosan-coated Polydioxanone loop suture (PDS plus looc, J&J), caliber 1, 48mm-cylindric needle. Group 3: Abdominal fascial closure will be performed with Polydioxanone loop suture (PDS plus looc, J&J), caliber 1, 48mm-cylindric needle. Incisional surgical.site infection and evisceration will be recorded.

Interventions

COMBINATION_PRODUCTTriclosan-coated barbed suture

Use of Triclosan-coated Polydioxanone barbed suture

COMBINATION_PRODUCTTriclosan-coated monofilament suture

Use of Triclosan-coated Polydioxanone monofilament suture

DEVICEMonofilament suture

Use of Polydioxanone monofilament suture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

The patient and the epidemiology nurse, who will assess the presence of SSI, will be blinded to the treatment assigned. The surgeon is masked to the assignment prior to consenting and enrolling the patient and initiating the surgery.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Contaminated and Dirty surgery * Emergency surgery performed by midline laparotomic approach * The following diagnosis will be included: * Anastomotic leak of previous digestive surgery (colon, small bowel or gastric surgery) * Colonic or bowel perforations * Appendicitis with purulent of fecal peritonitis, undergoing midline laparotomy * Perforation of gastric or duodenal ulcer * Intestinal ischemia requiring bowel resection

Exclusion criteria

* Emergency surgery undergoing laparoscopic approach * Appendicitis operated by McBurney incision * Intestinal isquemia without requiring bowel resection

Design outcomes

Primary

Measure	Time frame	Description
Rate of incisional surgical-site infection	30 days postoperatively	Diagnosis of incisional surgical-site infection during the postoperative course

Secondary

Measure	Time frame	Description
Rate of Evisceration	30 days postoperatively	Diagnosis of evisceration during the postoperative course, which will be assessed by physical examination

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026