Colorectal Resection Clinical Trial
Official title:
Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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