Back to resultsEffect of Triclosan-coated Suture on Superficial SSI
Primary Purpose
Surgical Site Infection
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Triclosan coated suture
No triclosan
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection focused on measuring Triclosan coated suture, Surgical site infection, Fecal peritonitis, Superficial, incisional
Eligibility Criteria
Inclusion Criteria:
- Fecal peritonitis
Exclusion Criteria:
- Perioperative mortality
Sites / Locations
- General University Hospital Elche
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Triclosan
No triclosan
Arm Description
Suture of the abdominal wall with triclosan coated suture
Suture of the abdominal wall with the same suture, but without triclosan
Outcomes
Primary Outcome Measures
Superficial surgical site infection (SSI)
SSI will be evaluated in the postoperative course and up to 60 days after surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT02018289
First Posted
December 17, 2013
Last Updated
December 20, 2013
Sponsor
Hospital General Universitario Elche
1. Study Identification
Unique Protocol Identification Number
NCT02018289
Brief Title
Effect of Triclosan-coated Suture on Superficial SSI
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche
4. Oversight
5. Study Description
Brief Summary
The abdominal closure with triclosan coated suture will reduce superficial surgical site infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Triclosan coated suture, Surgical site infection, Fecal peritonitis, Superficial, incisional
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triclosan
Arm Type
Experimental
Arm Description
Suture of the abdominal wall with triclosan coated suture
Arm Title
No triclosan
Arm Type
Sham Comparator
Arm Description
Suture of the abdominal wall with the same suture, but without triclosan
Intervention Type
Procedure
Intervention Name(s)
Triclosan coated suture
Intervention Description
Suture of the abdominal wall with triclosan coated suture
Intervention Type
Procedure
Intervention Name(s)
No triclosan
Intervention Description
Suture of the abdominal wall with suture without triclosan coat
Primary Outcome Measure Information:
Title
Superficial surgical site infection (SSI)
Description
SSI will be evaluated in the postoperative course and up to 60 days after surgery
Time Frame
60 postoperative days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fecal peritonitis
Exclusion Criteria:
Perioperative mortality
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Ruiz-Tovar, MD, PhD
Organizational Affiliation
Hospital General Universitario de Elche
Official's Role
Principal Investigator
Facility Information:
Facility Name
General University Hospital Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Effect of Triclosan-coated Suture on Superficial SSI
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