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

Sponsor

University of Milano Bicocca (Other)

Overall Status

Completed

CT.gov ID

NCT01869257

Collaborator

(none)

279

Enrollment

Location

Arms

Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Resection	Device: Triclosan coated suture Device: regular suture	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

279 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control regular suture not coated with triclosan	Device: regular suture 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	Device: Triclosan coated suture The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture

Arm

Intervention/Treatment

Active Comparator: control

regular suture not coated with triclosan

Device: regular suture

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

Device: Triclosan coated suture

The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture

Outcome Measures

Primary Outcome Measures

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