Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery

Conditions
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Colorectal Resection

Intervention / Treatment
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* Device: Triclosan coated suture
* Device: regular suture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients candidate to elective colorectal resection Exclusion Criteria: no consent peritonitis hypersensitivity to triclosan ASA > 3 ongoing infections

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>regular suture not coated with triclosan | Device: regular suture<br>* The control arm will have the abdominal wound sutured with a regular non-coated suture<br>|
| Experimental: triclosan<br>Experimental group will receive abdominal wound closure with suture matherial that is coated with triclosan | Device: Triclosan coated suture<br>* The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of surgical site infection | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| overall wound complications |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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triclosan, colorectal, surgery, surgical site infection