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The aim of this study is to evaluate the safety and efficacy of using Stratafix (a type of symmetric, barbed, and coated suture) for abdominal wall closure in oncologic patients undergoing elective midline laparotomy, compared to the use of a monofilament suture following the Small Stitch technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratafix | Experimental | Midline laparotomy closure with Stratafix suture. |
|
| PDS plus | Active Comparator | Midline laparotomy closure with PDS plus suture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stratafix Suture | Device | Midline laparotomy closure using Stratafix vs PDS plus. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incisional hernia | Incisional hernia rate after midline laparotomy closure. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Wound infection | Compare the wound infection rate after midline laparotomy closure with Stratafix vs PDS plus. | 12 months. |
| Wound seroma | Compare the wound seroma rate after midline laparotomy closure with Stratafix vs PDS plus. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
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| PDS plus suture |
| Device |
Midline laparotomy closure using PDS plus. |
|
| 12 months |
| Hematoma | Compare the hematoma rate after midline laparotomy closure with Stratafix vs PDS plus. | 12 months |
| Evisceration | Compare the evisceration rate after midline laparotomy closure with Stratafix vs PDS plus. | 1 month |
| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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