A Phase 3 interventional study of Triclosan-coated barbed suture and Triclosan-coated monofilament suture in Surgical Site Infection, sponsored by Hospital General Universitario Elche. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-16.
Sponsored by Hospital General Universitario Elche · Phase 3, Interventional, and Prevention
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.
670 studies on the registry are indexed under Surgical Wound Infection; 141 are open to participants now.
This study's enrollment of 150 is below the median of 200 across 514 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Hospital General Universitario Elche is the lead sponsor of 43 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The following diagnosis will be included:
Exclusion Criteria:
Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone barbed suture
Combination Product: Triclosan-coated barbed suture
Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone monofilament suture
Combination Product: Triclosan-coated monofilament suture
Abdominal wall closure will be performed using a monofilament suture
Device: Monofilament suture
Use of Triclosan-coated Polydioxanone barbed suture
Use of Triclosan-coated Polydioxanone monofilament suture
Use of Polydioxanone monofilament suture
Rate of incisional surgical-site infection
Diagnosis of incisional surgical-site infection during the postoperative course
Time frame: 30 days postoperatively
Rate of Evisceration
Diagnosis of evisceration during the postoperative course, which will be assessed by physical examination
Time frame: 30 days postoperatively
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Hospital General Universitario Elche