An interventional study of Subcuticular monocryl suture and Subcuticular absorbable staple using Insorb device in Pregnancy, sponsored by Inova Health Care Services. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Inova Health Care Services · Not applicable, Interventional, and Other
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.
Inova Health Care Services is the lead sponsor of 84 studies on the registry; 20 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Absorbable Moncryl sutures for closure of cesarean skin incision
Procedure: Subcuticular monocryl suture
Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by CooperSurgical.
Device: Subcuticular absorbable staple using Insorb device
Under the skin suture placed by hand
Under the skin stapling device that delivers absorbable staples
Operating time
Total time for the procedure
Time frame: Time from the start of surgery through end of skin closure up to 8 hours
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.
Time frame: Up to six weeks post partum
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.
Time frame: up to 3 days post-operatively
Number of Adverse Events
Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis
Time frame: Up to 6 weeks post-partum
Number of participants with any unscheduled postpartum visit
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
Time frame: up to 30 days post-operatively
Skin Closure Time in Minutes
Minutes it takes for closure of the skin at time of surgery
Time frame: Time from start of skin closure to end of skin closure up to 2 hours
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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