NCT01869257

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: University of Milano Bicocca · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Resection

Interventions

Type	Name	Description
DEVICE	Triclosan coated suture	The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture
DEVICE	regular suture	The control arm will have the abdominal wound sutured with a regular non-coated suture

Timeline

• Start date: 2009-05-01
• Primary completion: 2013-03-01
• Completion: 2013-05-01
• First posted: 2013-06-05
• Last updated: 2013-06-05

Locations

1 site across 1 country: Italy