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Patients will be randomized 3 groups:
Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed Polydioxanone suture
Group 2:Abdominal fascial closure will be performed with Triclosan-coated monofilament Polydioxanone suture
Group 3: Abdominal fascial closure will be performed with monofilament Polydioxanone suture
Incisional surgical.site infection and evisceration will be recorded.
Patients will be randomized 3 groups:
Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed Polydioxanone suture (Stratafix Symmetric, J&J), caliber 1, 48mm-cylindric needle.
Group 2:Abdominal fascial closure will be performed with Triclosan-coated Polydioxanone loop suture (PDS plus looc, J&J), caliber 1, 48mm-cylindric needle.
Group 3: Abdominal fascial closure will be performed with Polydioxanone loop suture (PDS plus looc, J&J), caliber 1, 48mm-cylindric needle.
Incisional surgical.site infection and evisceration will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triclosan-coated barbed suture | Experimental | Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone barbed suture |
|
| Triclosan-coated monofilament suture | Experimental | Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone monofilament suture |
|
| Monofilament suture | Sham Comparator | Abdominal wall closure will be performed using a monofilament suture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triclosan-coated barbed suture | Combination Product | Use of Triclosan-coated Polydioxanone barbed suture |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of incisional surgical-site infection | Diagnosis of incisional surgical-site infection during the postoperative course | 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Evisceration | Diagnosis of evisceration during the postoperative course, which will be assessed by physical examination | 30 days postoperatively |
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Inclusion Criteria:
Contaminated and Dirty surgery
Emergency surgery performed by midline laparotomic approach
The following diagnosis will be included:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andres Garcia-Marin | Hospital de San Juan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital Elche | Elche | Alicante | 03203 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32113031 | Derived | Ruiz-Tovar J, Llavero C, Jimenez-Fuertes M, Duran M, Perez-Lopez M, Garcia-Marin A. Incisional Surgical Site Infection after Abdominal Fascial Closure with Triclosan-Coated Barbed Suture vs Triclosan-Coated Polydioxanone Loop Suture vs Polydioxanone Loop Suture in Emergent Abdominal Surgery: A Randomized Clinical Trial. J Am Coll Surg. 2020 May;230(5):766-774. doi: 10.1016/j.jamcollsurg.2020.02.031. Epub 2020 Feb 27. |
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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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The patient and the epidemiology nurse, who will assess the presence of SSI, will be blinded to the treatment assigned.
The surgeon is masked to the assignment prior to consenting and enrolling the patient and initiating the surgery.
| Triclosan-coated monofilament suture | Combination Product | Use of Triclosan-coated Polydioxanone monofilament suture |
|
| Monofilament suture | Device | Use of Polydioxanone monofilament suture |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |