An interventional study of INSORB: subcuticular stapling device and Subcuticular monocryl suture manufactured by Ethicon in Operative Time and Wound Heal, sponsored by The University of Texas Medical Branch, Galveston. Terminated at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by The University of Texas Medical Branch, Galveston · 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 UTMB. We will exclude women with intraamniotic infection, immunosuppression, active skin infection, those unlikely to be followed-up after delivery, or unable to provide consent.
The University of Texas Medical Branch, Galveston is the lead sponsor of 251 studies on the registry; 38 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon.
Device: Subcuticular monocryl suture manufactured by Ethicon
Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical.
Device: INSORB: subcuticular stapling device
Under the skin stapling device that delivers absorbable staples
Under the skin suture placed by hand
Operating Time
Total time for the procedure
Time frame: Start of surgery through end of skin closure in minutes
Wound Cosmesis
A digital photograph of the incision will be obtained on wound check visit POD 5-10 days. 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: Time of surgery through six weeks post partum
Number of Participants With Composite Wound Complication
Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers
Time frame: Time of surgery through 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: 5-10 days
Number of Adverse Events
Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis
Time frame: Time of surgery through six weeks post partum
Use of Resources
Postpartum clinic or emergency room visit within 30 days of delivery, need for imaging or other invasive procedures
Time frame: Time of surgery through six weeks post partum
Skin Closure Time in Minutes
The average of minutes it takes for closure of the skin at time of surgery through weeks post partum.
Time frame: Time of surgery through six weeks post partum
| Milestone | Suture Wound Closure | Absorbable Staple Wound Closure |
|---|---|---|
| Started | 59 | 56 |
| Completed | 59 | 56 |
| Not completed | 0 | 0 |
Total time for the procedure
| Minutes | Suture Wound Closure | Absorbable Staple Wound Closure |
|---|---|---|
| Operating Time | 69.2 ± 23.7 | 61.9 ± 21.2 |
A digital photograph of the incision will be obtained on wound check visit POD 5-10 days. 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.
| score on a scale | Suture Wound Closure | Absorbable Staple Wound Closure |
|---|---|---|
| Wound Cosmesis | 3.9 ± 1.0 | 3.2 ± 1.2 |
Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers
| Participants | Suture Wound Closure | Absorbable Staple Wound Closure |
|---|---|---|
| Number of Participants With Composite Wound Complication | 0 | 2 |
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.
| Units on a scale | Suture Wound Closure | Absorbable Staple Wound Closure |
|---|---|---|
| Post Operative Pain | .9 ± 2.2 | .7 ± 1.9 |
Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis
| Participants | Suture Wound Closure | Absorbable Staple Wound Closure |
|---|---|---|
| Number of Adverse Events | 0 | 0 |
Postpartum clinic or emergency room visit within 30 days of delivery, need for imaging or other invasive procedures
| Participants | Suture Wound Closure | Absorbable Staple Wound Closure |
|---|---|---|
| Use of Resources | 0 | 1 |
The average of minutes it takes for closure of the skin at time of surgery through weeks post partum.
| minutes | Suture Wound Closure | Absorbable Staple Wound Closure |
|---|---|---|
| Skin Closure Time in Minutes | 7.6 ± 2.7 | 4.1 ± 2.67 |
Collected over baseline until the end of the study, up to 6 weeks postpartum. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Suture Wound Closure | 0/59 (0%) | 0/59 (0%) | 0/59 (0%) |
| Absorbable Staple Wound Closure | 0/56 (0%) | 0/56 (0%) | 0/56 (0%) |
| Age, Continuous(years) | Suture Wound Closure | Absorbable Staple Wound Closure | Total |
|---|---|---|---|
| Mean | 29.5 ± 5 | 31.1 ± 5.2 | 30.3 ± 5.2 |
| Sex: Female, Male(Participants) | Suture Wound Closure | Absorbable Staple Wound Closure | Total |
|---|---|---|---|
| Female | 59 | 56 | 115 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Suture Wound Closure | Absorbable Staple Wound Closure | Total |
|---|---|---|---|
| Hispanic or Latino | 43 | 40 | 83 |
| Not Hispanic or Latino | 16 | 16 | 32 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Suture Wound Closure | Absorbable Staple Wound Closure | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 8 | 17 |
| White | 50 | 48 | 98 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Suture Wound Closure | Absorbable Staple Wound Closure | Total |
|---|---|---|---|
| United States | 59 | 56 | 115 |
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Plan to share: No — Do not plan to share IPD.
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The University of Texas Medical Branch, Galveston