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

Colorectal Resection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869257
• Other study ID #: CR-SSI 09
• Secondary ID: UNIMIB18
• Status: Completed
• Phase: Phase 3
• First received: May 24, 2013
• Last updated: May 30, 2013
• Start date: May 2009
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• patients candidate to elective colorectal resection

Exclusion Criteria:

• no consent

• peritonitis

• hypersensitivity to triclosan

• ASA > 3

• ongoing infections

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Resection
• Surgical Wound Infection

Intervention

Device:
• Triclosan coated suture
The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture
• regular suture
The control arm will have the abdominal wound sutured with a regular non-coated suture

Locations

Country	Name	City	State
Italy	San Gerardo Hospital	Monza

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Chang WK, Srinivasa S, Morton R, Hill AG. Triclosan-impregnated sutures to decrease surgical site infections: systematic review and meta-analysis of randomized trials. Ann Surg. 2012 May;255(5):854-9. doi: 10.1097/SLA.0b013e31824e7005. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	length of hospital stay		30 days	No
Primary	Rate of surgical site infection	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	30 days	No
Secondary	overall wound complications		30 days	No

External Links

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