Colorectal ResectionPhase 3NCT01869257
Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery
A Phase 3 study testing Triclosan coated suture and regular suture in people with Colorectal Resection, run by University of Milano Bicocca at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Resection
- What is being tested?
- Triclosan coated suture and regular suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 siteItaly
- Study dates
- May 2009to May 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients candidate to elective colorectal resection
Who cannot join
- no consent
- peritonitis
- hypersensitivity to triclosan
- ASA > 3
- ongoing infections
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Colorectal Resection
- Being tested
- Triclosan coated suture, regular suture
- Keywords
- triclosan, colorectal, surgery, surgical site infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triclosan coated sutureDevice
The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture
regular sutureDevice
The control arm will have the abdominal wound sutured with a regular non-coated suture
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | regular suture not coated with triclosan Receives: Device: regular suture |
| triclosan | Experimental | Experimental group will receive abdominal wound closure with suture matherial that is coated with triclosan Receives: Device: Triclosan coated suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (1)
overall wound complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startMay 2009
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal ResectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Vittorio Gianotti, University of Milano Bicocca
- Investigators
- Angelo Nespoli, MD, Study chair, Milano-Bicocca University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869257
- Sponsor's protocol ID
- CR-SSI 09
- Other IDs
- UNIMIB18
- Status last verified
- May 2013
- First submitted
- 24 May 2013
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22470067
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01869257
- Acronym / sponsor ID
- CR-SSI 09
- Conditions
- Colorectal Resection
- Keywords
- triclosan, colorectal, surgery, surgical site infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Device: regular sutureregular suture not coated with triclosan |
| triclosan | Experimental | Device: Triclosan coated sutureExperimental group will receive abdominal wound closure with suture matherial that is coated with triclosan |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients candidate to elective colorectal resection
Key exclusion criteria (5 listed)
- no consent
- peritonitis
- hypersensitivity to triclosan
- ASA > 3
- ongoing infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triclosan coated sutureThe patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture | Device | triclosan |
| regular sutureThe control arm will have the abdominal wound sutured with a regular non-coated suture | Device | control |
Primary outcome
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
1 secondary outcome
overall wound complications
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
- Background: PubMed 22470067Chang 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelo Nespoli, MD study chair
Milano-Bicocca University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triclosan coated suture and regular suture in people with Colorectal Resection, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of surgical site infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01869257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.