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

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03763279
• Other study ID #: HRJC-HUSJ 18-10
• Status: Completed
• Phase: Phase 3
• Start date: November 30, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: September 2019
• Source: Hospital General Universitario Elche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Combination Product:
• Triclosan-coated barbed suture
Use of Triclosan-coated Polydioxanone barbed suture
• Triclosan-coated monofilament suture
Use of Triclosan-coated Polydioxanone monofilament suture

Device:
• Monofilament suture
Use of Polydioxanone monofilament suture

Locations

Country	Name	City	State
Spain	General Hospital Elche	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of incisional surgical-site infection	Diagnosis of incisional surgical-site infection during the postoperative course	30 days postoperatively
Secondary	Rate of Evisceration	Diagnosis of evisceration during the postoperative course, which will be assessed by physical examination	30 days postoperatively