- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01869257
Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery
Despite adequate antimicrobial prophylaxis and perioperative correction of risk factors, surgical site infections (SSI) remain the most frequent complication of colorectal resection (range 10-17%). Several strategies may be implemented to prevent SSI. Among these, the use of local antimicrobial agents seems successful.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a non-sponsored, multicenter, prospective, randomized, controlled, single-blind study. Two hundred and seventy-three patients candidate to colorectal resection were enrolled. Exclusion criteria were: age < 18 or > 85 years, pregnancy, peritonitis, peritoneal contamination during operation, ongoing infections, ASA score > 3, denied consent.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Monza, Italy, 20900
- San Gerardo Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients candidate to elective colorectal resection
Exclusion Criteria:
- no consent
- peritonitis
- hypersensitivity to triclosan
- ASA > 3
- ongoing infections
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: control
regular suture not coated with triclosan
|
The control arm will have the abdominal wound sutured with a regular non-coated suture
|
Experimental: triclosan
Experimental group will receive abdominal wound closure with suture matherial that is coated with triclosan
|
The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of surgical site infection
Time Frame: 30 days
|
the incidence of superficial and deep wound infection in patients who underwent colorectal resection will be determined by a blind observer according to the Atlanta CDC definition. The unit of measure will be number of wound infection over the number of treated or control patients |
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall wound complications
Time Frame: 30 days
|
30 days
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
length of hospital stay
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Angelo Nespoli, MD, Milano-Bicocca University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Wound Infection
- Infections
- 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
- CR-SSI 09
- UNIMIB18 (Other Identifier: Milano-Bicocca University)
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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