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

Primary Purpose

Colorectal Resection

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Triclosan coated suture
regular suture
Sponsored by
University of Milano Bicocca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Resection focused on measuring triclosan, colorectal, surgery, surgical site infection

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients candidate to elective colorectal resection

Exclusion Criteria:

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

Sites / Locations

  • San Gerardo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control

triclosan

Arm Description

regular suture not coated with triclosan

Experimental group will receive abdominal wound closure with suture matherial that is coated with triclosan

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

overall wound complications

Full Information

First Posted
May 24, 2013
Last Updated
May 30, 2013
Sponsor
University of Milano Bicocca
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1. Study Identification

Unique Protocol Identification Number
NCT01869257
Brief Title
Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery
Official Title
Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milano Bicocca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Resection
Keywords
triclosan, colorectal, surgery, surgical site infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
279 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Active Comparator
Arm Description
regular suture not coated with triclosan
Arm Title
triclosan
Arm Type
Experimental
Arm Description
Experimental group will receive abdominal wound closure with suture matherial that is coated with triclosan
Intervention Type
Device
Intervention Name(s)
Triclosan coated suture
Intervention Description
The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture
Intervention Type
Device
Intervention Name(s)
regular suture
Intervention Description
The control arm will have the abdominal wound sutured with a regular non-coated suture
Primary Outcome Measure Information:
Title
Rate of surgical site infection
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
overall wound complications
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
length of hospital stay
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients candidate to elective colorectal resection Exclusion Criteria: no consent peritonitis hypersensitivity to triclosan ASA > 3 ongoing infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo Nespoli, MD
Organizational Affiliation
Milano-Bicocca University
Official's Role
Study Chair
Facility Information:
Facility Name
San Gerardo Hospital
City
Monza
ZIP/Postal Code
20900
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22470067
Citation
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.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/
Description
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Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery

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