Cesarean DeliveryNCT06412978
Post-Operative Cesarean Section Cosmesis
A study testing absorbable subcuticular polyglycolic acid staples (INSORB) and subcuticular, polyglecaprone suture (Monocryl) in people with Cesarean Delivery, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Several recent reviews have summarized the evidence for various steps of cesarean delivery, but surprisingly in many cases there is little scientific evidence on which to base the choice of… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- absorbable subcuticular polyglycolic acid staples (INSORB) and subcuticular, polyglecaprone suture (Monocryl)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2024to Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-44
- Any race
- Any parity
- Scheduled cesarean section
- Neuraxial analgesia
Who cannot join
- Non-English Speaking
- Incarcerated
- Maternal Connective Tissue Disorder
- Systemic maternal steroid use
- Three prior cesarean deliveries
- Body Mass Index (BMI) >40
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Christina Tulbert, 336-716-2383, Christina.Tulbert@Advocatehealth.org
Joshua F Nitsche, MD
About this study
Official title: Post-Operative Cosmesis and Skin Closure Methods After Cesarean Section
Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Several recent reviews have summarized the evidence for various steps of cesarean delivery, but surprisingly in many cases there is little scientific evidence on which to base the choice of surgical technique.
Read the detailed description
Cesarean delivery is the most common surgical procedure performed in the United States, with over 1 million procedures performed per year. Based on recent Center for Disease Control (CDC) National Vital Statistics Report (2021) 32.1% of all births in the United States were via cesarean delivery. Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Absorbable staples, made from a combination of polylactic and polyglycolic acid, are a relatively new option for skin closure at the time of surgery. This study is a randomized trial that will investigates two cesarean skin closure techniques-subcuticular, polyglecaprone suture (Monocryl), and absorbable subcuticular polyglycolic acid staples (INSORB)-to determine if one is associated with better scar cosmesis.
- Conditions
- Cesarean Delivery
- Being tested
- absorbable subcuticular polyglycolic acid staples (INSORB), subcuticular, polyglecaprone suture (Monocryl)
- Keywords
- cosmetic improvement, surgical correction, Cosmesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
absorbable subcuticular polyglycolic acid staples (INSORB)Procedure or surgery
Also called INSORB
Insorb absorbable staples are used for skin closure
subcuticular, polyglecaprone suture (Monocryl)Procedure or surgery
Also called Monocryl
Monocryl absorbable staples are used for skin closure
| Study group | Role | What they receive |
|---|---|---|
| subcuticular absorbable polyglycolic acid (INSORB) staples | Active comparator | Insorb absorbable staples are used for skin closure Receives: Procedure: absorbable subcuticular polyglycolic acid staples (INSORB) |
| subcuticular absorbable polyglecaprone suture (Monocryl) | Active comparator | Monocryl absorbable staples are used for skin closure Receives: Procedure: subcuticular, polyglecaprone suture (Monocryl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
scar cosmetic score
Scars will be digitally photographed by study staff and scored by 2 independent judges (attending Obstetricians) according to the SCAR scale validated by Kantor with scores ranging from 0 (best) to 15 (worst).
Measured: Week 6
Secondary outcomes (7)
Number of Wound complications
wound complications (infection, dehiscence, seroma, hematoma, skin and fat necrosis, skin and fascial dehiscence)
Measured: Week 6
length of hospital stay
days spent in hospital
Measured: Week 6
amount of in-hospital intravenous opiate analgesic use
amount of in-hospital intravenous opiate analgesic use
Measured: Week 6
amount of in-hospital oral NSAID analgesic use
amount of in-hospital oral NSAID analgesic use
Measured: Week 6
amount of in-hospital oral opiate analgesic use
amount of in-hospital oral opiate analgesic use
Measured: Week 6
patient rated subjective pain score
patient rated subjective pain score (0-10 based on visual analog scale) - 100-mm visual analog scale (VAS) ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
Measured: Week 6
patient's overall satisfaction with cosmesis scores
The Patient and Observer Scar Assessment Scale (POSASA) All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). Higher scores meaning more scarring
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start5 Sep 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- trial comparing skin closure with absorbable subcuticular staples with subcuticular suture
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua F Nitsche, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412978
- Sponsor's protocol ID
- IRB00109639
- Status last verified
- Mar 2026
- First submitted
- 8 May 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the participant data collected during the trial and after deidentification