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

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Surgical Site Infection

Treatments: Combination Product: Triclosan-coated barbed suture; Device: Monofilament suture; Combination Product: Triclosan-coated monofilament suture

Study type: Interventional

Funder types: Other

Identifiers

NCT03763279

HRJC-HUSJ 18-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Triclosan-coated barbed suture

Experimental group

Description:

Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone barbed suture

Treatment:

Combination Product: Triclosan-coated barbed suture

Triclosan-coated monofilament suture

Experimental group

Description:

Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone monofilament suture

Treatment:

Combination Product: Triclosan-coated monofilament suture

Monofilament suture

Sham Comparator group

Description:

Abdominal wall closure will be performed using a monofilament suture

Treatment:

Device: Monofilament suture