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Completed

NCT Number: NCT01869257

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.

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Key information

Conditions

Colorectal Resection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

San Gerardo Hospital

Monza, 20900, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients candidate to elective colorectal resection

Exclusion criteria

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

Treatment and study plan

Triclosan coated suture

Device

The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture

regular suture

Device

The control arm will have the abdominal wound sutured with a regular non-coated suture

Primary outcomes

  1. 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

  1. overall wound complications

    Time frame: 30 days

Other outcomes

  1. length of hospital stay

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 5, 2013
Registry last updated
Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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