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Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics
This will be an open-label randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have either standard wound closure with Monocryl suture or absorbable subcuticular staples placed by INSORB skin stapling device. The INSORB under the skin stapling device is FDA approved but not currently used as standard of care at Inova. We will exclude women with intraamniotic infection, immunosuppression, active skin infection, those unlikely to be followed-up after delivery, or unable to provide consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suture wound closure | Active Comparator | Absorbable Moncryl sutures for closure of cesarean skin incision |
|
| Absorbable staple wound closure | Experimental | Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by CooperSurgical. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcuticular monocryl suture | Procedure | Under the skin suture placed by hand |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Operating time | Total time for the procedure | Time from the start of surgery through end of skin closure up to 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Cosmesis | A digital photograph of the incision will be obtained on wound check visit POD 5-10 days and 4-6 weeks post partum. Each photograph will be evaluated by independent blinded research staff using the Stony Brook Scar Evaluation Scale. These scores are totaled to obtain the final score. The Stony Brook Scar Evaluation will score the scar from 0-5 where 5 shows significant healing. | Up to six weeks post partum |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis | Up to 6 weeks post-partum |
| Number of participants with any unscheduled postpartum visit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Saad, MD | Contact | (703) 779-6040 | antonio.saad@inova.org | |
| Michelle L Cassidy, PhD, RN | Contact | (703) 776-4600 | michelle.cassidy@inova.org |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Saad, MD | Inova Fairfax Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | United States |
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Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation
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Reviewers of wound cosmetics during the post operative time will be blind to the intervention. However, surgeon at the time skin closure and patient will not be blinded to the intervention.
| Subcuticular absorbable staple using Insorb device |
| Device |
Under the skin stapling device that delivers absorbable staples |
|
| Post Operative Pain | Analog pain scale ranging from 0-10. This is a standard question that nurses as during the post partum period while in the hospital and clinic/nursing visits. The numerical score will be recorded from the patient's chart. A score of 0 means no pain, and 10 means the worst pain. | up to 3 days post-operatively |
Any additional postpartum clinic appointments for medical or clinical concerns beyond the routinely scheduled visits. Participants are counted once, regardless of number or type of visits
| up to 30 days post-operatively |
| Skin Closure Time in Minutes | Minutes it takes for closure of the skin at time of surgery | Time from start of skin closure to end of skin closure up to 2 hours |