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

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Triclosan-coated barbed suture
Triclosan-coated monofilament suture
Monofilament suture
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • General Hospital Elche

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Triclosan-coated barbed suture

Triclosan-coated monofilament suture

Monofilament suture

Arm Description

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

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

Abdominal wall closure will be performed using a monofilament suture

Outcomes

Primary Outcome Measures

Rate of incisional surgical-site infection
Diagnosis of incisional surgical-site infection during the postoperative course

Secondary Outcome Measures

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

Full Information

First Posted
November 30, 2018
Last Updated
September 12, 2019
Sponsor
Hospital General Universitario Elche
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1. Study Identification

Unique Protocol Identification Number
NCT03763279
Brief Title
Effect of Barbed Suture and Triclosan-coated Monofilament in Emergency Surgery
Official Title
Suture of the Abdominal Wall With Triclosan-coated Polydioxanone Barbed Suture vs Triclosan-coated Polydioxanone Monofilament vs Polydioxanone Monofilament in Emergency Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triclosan-coated barbed suture
Arm Type
Experimental
Arm Description
Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone barbed suture
Arm Title
Triclosan-coated monofilament suture
Arm Type
Experimental
Arm Description
Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone monofilament suture
Arm Title
Monofilament suture
Arm Type
Sham Comparator
Arm Description
Abdominal wall closure will be performed using a monofilament suture
Intervention Type
Combination Product
Intervention Name(s)
Triclosan-coated barbed suture
Intervention Description
Use of Triclosan-coated Polydioxanone barbed suture
Intervention Type
Combination Product
Intervention Name(s)
Triclosan-coated monofilament suture
Intervention Description
Use of Triclosan-coated Polydioxanone monofilament suture
Intervention Type
Device
Intervention Name(s)
Monofilament suture
Intervention Description
Use of Polydioxanone monofilament suture
Primary Outcome Measure Information:
Title
Rate of incisional surgical-site infection
Description
Diagnosis of incisional surgical-site infection during the postoperative course
Time Frame
30 days postoperatively
Secondary Outcome Measure Information:
Title
Rate of Evisceration
Description
Diagnosis of evisceration during the postoperative course, which will be assessed by physical examination
Time Frame
30 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres Garcia-Marin
Organizational Affiliation
Hospital de San Juan
Official's Role
Study Director
Facility Information:
Facility Name
General Hospital Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
32113031
Citation
Ruiz-Tovar J, Llavero C, Jimenez-Fuertes M, Duran M, Perez-Lopez M, Garcia-Marin A. Incisional Surgical Site Infection after Abdominal Fascial Closure with Triclosan-Coated Barbed Suture vs Triclosan-Coated Polydioxanone Loop Suture vs Polydioxanone Loop Suture in Emergent Abdominal Surgery: A Randomized Clinical Trial. J Am Coll Surg. 2020 May;230(5):766-774. doi: 10.1016/j.jamcollsurg.2020.02.031. Epub 2020 Feb 27.
Results Reference
derived

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

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