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| ID | Type | Description | Link |
|---|---|---|---|
| UNIMIB18 | Other Identifier | Milano-Bicocca University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Active Comparator | regular suture not coated with triclosan |
|
| triclosan | Experimental | Experimental group will receive abdominal wound closure with suture matherial that is coated with triclosan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triclosan coated suture | Device | The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| overall wound complications | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| length of hospital stay | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angelo Nespoli, MD | Milano-Bicocca University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Gerardo Hospital | Monza | 20900 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22470067 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| regular suture | Device | The control arm will have the abdominal wound sutured with a regular non-coated suture |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |