- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03763279
Effect of Barbed Suture and Triclosan-coated Monofilament in Emergency Surgery
Suture of the Abdominal Wall With Triclosan-coated Polydioxanone Barbed Suture vs Triclosan-coated Polydioxanone Monofilament vs Polydioxanone Monofilament in Emergency Surgery
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Alicante
-
Elche, Alicante, Spain, 03203
- General Hospital Elche
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Triclosan-coated barbed suture
Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone barbed suture
|
Use of Triclosan-coated Polydioxanone barbed suture
|
Experimental: Triclosan-coated monofilament suture
Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone monofilament suture
|
Use of Triclosan-coated Polydioxanone monofilament suture
|
Sham Comparator: Monofilament suture
Abdominal wall closure will be performed using a monofilament suture
|
Use of Polydioxanone monofilament suture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of incisional surgical-site infection
Time Frame: 30 days postoperatively
|
Diagnosis of incisional surgical-site infection during the postoperative course
|
30 days postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Evisceration
Time Frame: 30 days postoperatively
|
Diagnosis of evisceration during the postoperative course, which will be assessed by physical examination
|
30 days postoperatively
|
Collaborators and Investigators
Investigators
- Study Director: Andres Garcia-Marin, Hospital de San Juan
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Postoperative Complications
- Disease Attributes
- Wound Infection
- Emergencies
- Surgical Wound Infection
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Antimetabolites
- Hypolipidemic Agents
- Lipid Regulating Agents
- Fatty Acid Synthesis Inhibitors
- Triclosan
Other Study ID Numbers
- HRJC-HUSJ 18-10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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