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The objective of this study was to compare the an adhesive latch device (" Dermaclip") to subcuticular skin closure at the time of cesarean section. Currently, no studies exist comparing these two closure techniques. The hypothesis is dermaclip closure is faster than subcuticular closure. The null hypothesis is there is no difference in closure times. There is a study (see reference at bottom) that compares staples closure to subcuticular closure, but none comparing subcuticular to dermaclip closure. Dermaclip device is easily deployed and is expected to be as fast as staples closure compared to subcuticular as noted in the prior study referenced below.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcuticular arm | Active Comparator | closure technique that the Adhesive Latch arem (dermaclip) arm is being compared to |
|
| Adhesive Latch Arm (Demaclip arm) | Active Comparator | This is the arm which the adhesive latch system is used and it is being compared to the arm of subcuticular |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermaclip | Device | Dermaclip is an adhesive latch device used for skin closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of adhesive latch device to subcuticular skin closure at the time of cesarean section | The time for skin closure between subcuticular and demaclip techniques will compared during cesarean section | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | - pain scores using the visual analog pain scale (VAPS) system | 18 months |
| Wound Infections as measured in centimeters of erythema | - wound infections will measured in centimeters of redness/erythema around the infected area |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rubino OBGYN Group | Recruiting | West Orange | New Jersey | 07052 | United States |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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A control group of subcuticular closure and the experimental group is skin closure withthe adhesive latch device ("dermaclip")
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computer randomized list of closure type opened from a sealed envelope on the day of surgery
| Subcuticular suture | Device | subcuticular suture will be used as the device to close the skin in this arm |
|
|
| 18 months |
| Wound separation as measured in centimeters | - wound separation will be recorded centimeters | 18 months |
| Patient Satisfaction scores | - patient satisfaction | 18 months |
| Total surgery time | - total surgery time | 18 months |
| Age | - age (years) | 18 months |
| BMI | BMI of participants bmi (in kg/m2, weight in kg, height, in meters) | 18 months |
| Ethnicity | Ethnic origin | 18 months |
| Race | Race of participants | 18 months |