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Collaborator discontinued at this site to pursue the study with a different site.
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| Name | Class |
|---|---|
| Clinical Innovations | INDUSTRY |
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This is an unblinded, randomized control trial of obese women to evaluate the impact of the Traxi Panniculus Retractor (TPR) on the cesarean operative time and surgical blood loss when compared to silk tape.
The purpose of the study is to assess whether using the Traxi Panniculus Retractor during cesarean section, in obese (BMI greater than or equal to 30kg/m2 at time of delivery) women, can decrease the cesarean operative time compared to using silk tape to retract the panniculus. Operative time is defined as the time from when the patient lies on the operating room table (at completion of the epidural/spinal anesthesia) until fascial closure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPR Arm | Experimental | Surgeon will use the Traxi Panniculus Retractor to retract the panniculus during cesarean section. |
|
| Silk Tape Arm | Active Comparator | Surgeon will use silk tape to retract the panniculus during cesarean section. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traxi Panniculus Retractor (TPR) | Other | Surgeon uses the Traxi Panniculus Retractor (TPR) surgical retraction device to retract the panniculus during C-Section. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from when a subject lies on the OR table to fascial closure | During surgery-Time from when a subject lies on the OR table to fascial closure |
| Measure | Description | Time Frame |
|---|---|---|
| Time from skin incision to delivery | During surgery-skin incision to delivery | |
| Time from hysterotomy to delivery | During surgery-hysterotomy to delivery | |
| Time from skin incision to closure of fascia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Paglia, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Medical Center | Danville | Pennsylvania | 17821 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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No Masking
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| Silk Tape | Other | Surgeon uses silk tape to retract the panniculus during C-Section. |
|
| During surgery-skin incision to closure of fascia |
| Time from skin incision to skin closure | During surgery-skin incision to skin closure |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |