Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Milano Bicocca
- Enrollment
- 279
- Locations
- 1
- Primary Endpoint
- Rate of surgical site infection
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients candidate to elective colorectal resection
Exclusion Criteria
- •no consent
- •peritonitis
- •hypersensitivity to triclosan
- •ongoing infections
Arms & Interventions
control
regular suture not coated with triclosan
Intervention: regular suture (Device)
triclosan
Experimental group will receive abdominal wound closure with suture matherial that is coated with triclosan
Intervention: Triclosan coated suture (Device)
Outcomes
Primary Outcomes
Rate of surgical site infection
Time Frame: 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 Outcomes
- overall wound complications(30 days)
Investigators
Luca Vittorio Gianotti
Researcher
University of Milano Bicocca