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| Name | Class |
|---|---|
| Russell J.Stankiewicz, MD | UNKNOWN |
| Ob/GYN Associates of Evangelical Hospital | UNKNOWN |
| The Commonwealth Medical College | UNKNOWN |
| Nickolas Serniak, BS, MS 4 |
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Prospective single blinded trial comparing standard synthetic suture material to a synthetic barbed suture in closure of uterine incision, during Cesarean section procedures.
Cesarean section is one of the most common medical procedures women of child bearing age undergo, in the United States and the world. This trial is designed to provide information and possible recommendation as to suture material used during closure of the uterus during that procedure. Our intent is to provide data relating to time of uterine closure, blood loss, and post operative pain. These conclusions may provide substantiated recommendations as to self locking and tying suture material in the performance of cesarean section as related to readily available synthetic suture material, which has the need for standard suture knot placement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Group of patients receiving standard hysterotomy closure with synthetic braided suture |
|
| Stratfix | Experimental | group of patients having the hysterotomy incision closed with barbed synthetic suture. Time to closure, blood loss, and postoperative pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stratafix synthetic barbed suture | Procedure | hysterotomy closure in Cesarian section |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss in closure with barbed synthetic suture | monitoring of preoperative and postoperative hemoglobin and hematcrit | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Post operative pain after cesarean secton | using visual analog pain scale, compare standard closure to barbed suture closure pain | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| time to close uterine hysterotomy incision comparing standard and barbed suture | comparing time to closure hysterotomy incision of standard suture verse barbed suture | total time comparision of closure rates over course of study period (2 years) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evangelical Community Hospital | Lewisburg | Pennsylvania | 17837 | United States |
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| UNKNOWN |
| Neil Cooper, MS, MS 4 | UNKNOWN |
| Jennifer L. MacDonald, PA | UNKNOWN |
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