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

Hospital General Universitario Elche150 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

150

Conditions

Surgical Site Infection

Interventions

Triclosan-coated barbed sutureCOMBINATION_PRODUCT

Use of Triclosan-coated Polydioxanone barbed suture

Triclosan-coated monofilament sutureCOMBINATION_PRODUCT

Use of Triclosan-coated Polydioxanone monofilament suture

Monofilament sutureDEVICE

Use of Polydioxanone monofilament suture

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

General Hospital Elche

Elche, Alicante, Spain

Outcomes

Primary Outcomes

Rate of incisional surgical-site infection

Diagnosis of incisional surgical-site infection during the postoperative course

Time frame: 30 days postoperatively

Secondary Outcomes

Rate of Evisceration

Diagnosis of evisceration during the postoperative course, which will be assessed by physical examination

Time frame: 30 days postoperatively

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.