Colorectal Resection
Conditions
Keywords
triclosan, colorectal, surgery, surgical site infection
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.
Interventions
DEVICETriclosan coated suture
The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture
DEVICEregular suture
The control arm will have the abdominal wound sutured with a regular non-coated suture
Sponsors
University of Milano Bicocca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* patients candidate to elective colorectal resection
Exclusion criteria
* no consent * peritonitis * hypersensitivity to triclosan * ASA \> 3 * ongoing infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| overall wound complications | 30 days |
Other
| Measure | Time frame |
|---|---|
| length of hospital stay | 30 days |
Countries
Italy
Outcome results
None listed