Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery
NCT ID: NCT01869257
Last Updated: 2013-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
279 participants
INTERVENTIONAL
2009-05-31
2013-05-31
Brief Summary
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The primary aim of the present trial was to evaluate the efficacy of a surgical suture, coated with Triclosan a synthetic soluble antimicrobial agent, in reducing the SSI rate after colorectal operations.
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Detailed Description
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135 were randomized to the treatment arm and 136 to the control arm. Treatment consisted of abdominal wound closure by suturing peritoneum, fascia, subcutaneous tissue, and skin with Polyglactin 910 Triclosan-coated suture (treatment arm) or with Polyglactin without Triclosan (control arm). SSI were defined according to the Atlanta CDC. Patients were followed up by office visits for 30 days after discharge.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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control
regular suture not coated with triclosan
regular suture
The control arm will have the abdominal wound sutured with a regular non-coated suture
triclosan
Experimental group will receive abdominal wound closure with suture matherial that is coated with triclosan
Triclosan coated suture
The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture
Interventions
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Triclosan coated suture
The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture
regular suture
The control arm will have the abdominal wound sutured with a regular non-coated suture
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* peritonitis
* hypersensitivity to triclosan
* ASA \> 3
* ongoing infections
18 Years
85 Years
ALL
No
Sponsors
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University of Milano Bicocca
OTHER
Responsible Party
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Luca Vittorio Gianotti
Researcher
Principal Investigators
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Angelo Nespoli, MD
Role: STUDY_CHAIR
Milano-Bicocca University
Locations
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San Gerardo Hospital
Monza, , Italy
Countries
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References
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Chang WK, Srinivasa S, Morton R, Hill AG. Triclosan-impregnated sutures to decrease surgical site infections: systematic review and meta-analysis of randomized trials. Ann Surg. 2012 May;255(5):854-9. doi: 10.1097/SLA.0b013e31824e7005.
Related Links
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Related Info
Other Identifiers
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UNIMIB18
Identifier Type: OTHER
Identifier Source: secondary_id
CR-SSI 09
Identifier Type: -
Identifier Source: org_study_id
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