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NCT02018289 Clinical Trial

Effect of Triclosan-coated Suture on Superficial SSI

Surgical Site Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02018289
Other study ID # 2013-0010
Secondary ID
Status Completed
Phase Phase 3
First received December 17, 2013
Last updated December 20, 2013
Start date October 2007

Study information
Verified date December 2013
Source Hospital General Universitario Elche
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial Summary

The abdominal closure with triclosan coated suture will reduce superficial surgical site infection.

Recruitment information / eligibility
Status Completed
Enrollment 106
Est. completion date
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Fecal peritonitis

Exclusion Criteria:

- Perioperative mortality

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• Triclosan coated suture
Suture of the abdominal wall with triclosan coated suture
• No triclosan
Suture of the abdominal wall with suture without triclosan coat

Locations
Country Name City State
Spain General University 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 Superficial surgical site infection (SSI) SSI will be evaluated in the postoperative course and up to 60 days after surgery 60 postoperative days Yes
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