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

Phase 3

Completed

• Conditions: Colorectal Resection
• Interventions: Device: regular suture; Device: Triclosan coated suture

• Registration Number: NCT01869257
• Lead Sponsor: University of Milano Bicocca

Brief Summary

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

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 Timeline

• Study Start: 2009-05
• Primary Completion: 2013-03
• Status Verified: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-05-30
• Last Update Submitted: 2013-05-30
• Study First Posted: 2013-06-05
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

Inclusion Criteria

• patients candidate to elective colorectal resection

Exclusion Criteria

• no consent
• peritonitis
• hypersensitivity to triclosan
• ASA > 3
• ongoing infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	regular suture	regular suture not coated with triclosan
triclosan	Triclosan coated suture	Experimental group will receive abdominal wound closure with suture matherial that is coated with triclosan

Primary Outcome Measures

Name	Time	Method
Rate of surgical site infection	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

Secondary Outcome Measures

Name	Time	Method
overall wound complications	30 days

Trial Locations

Locations (1)

San Gerardo Hospital; 🇮🇹 Monza, Italy