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

Phase 3

Completed

• Conditions: Surgical Site Infection
• Interventions: Device: Monofilament suture; Combination Product: Triclosan-coated barbed suture; Combination Product: Triclosan-coated monofilament suture

• Registration Number: NCT03763279
• Lead Sponsor: Hospital General Universitario Elche

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.

Study Timeline

• Study Start: 2018-11-30
• Study First Submitted: 2018-11-30
• Study First Submitted QC: 2018-11-30
• Study First Posted: 2018-12-04
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-12
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monofilament suture	Monofilament suture	Abdominal wall closure will be performed using a monofilament suture
Triclosan-coated barbed suture	Triclosan-coated barbed suture	Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone barbed suture
Triclosan-coated monofilament suture	Triclosan-coated monofilament suture	Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone monofilament suture

Primary Outcome Measures

Name	Time	Method
Rate of incisional surgical-site infection	30 days postoperatively	Diagnosis of incisional surgical-site infection during the postoperative course

Secondary Outcome Measures

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

Trial Locations

Locations (1)

General Hospital Elche; 🇪🇸 Elche, Alicante, Spain