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

U

University of Milano Bicocca

Status and phase

Completed
Phase 3

Conditions

Colorectal Resection

Treatments

Device: regular suture
Device: Triclosan coated suture

Study type

Interventional

Funder types

Other

Identifiers

NCT01869257
CR-SSI 09
UNIMIB18 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

279 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients candidate to elective colorectal resection

Exclusion criteria

  • no consent
  • peritonitis
  • hypersensitivity to triclosan
  • ASA > 3
  • ongoing infections

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

279 participants in 2 patient groups

control
Active Comparator group
Description:
regular suture not coated with triclosan
Treatment:
Device: regular suture
triclosan
Experimental group
Description:
Experimental group will receive abdominal wound closure with suture matherial that is coated with triclosan
Treatment:
Device: Triclosan coated suture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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