A Phase 3 interventional study of Triclosan coated suture and regular suture in Colorectal Resection, sponsored by University of Milano Bicocca. Completed at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-06-05.
Sponsored by University of Milano Bicocca · Phase 3, Interventional, and Treatment
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 279 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University of Milano Bicocca is the lead sponsor of 124 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
regular suture not coated with triclosan
Device: regular suture
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
The control arm will have the abdominal wound sutured with a regular non-coated suture
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
Time frame: 30 days
overall wound complications
Time frame: 30 days
length of hospital stay
Time frame: 30 days
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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University of Milano Bicocca