Post-Operative Cesarean Section Cosmesis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: absorbable subcuticular polyglycolic acid staples (INSORB), subcuticular, polyglecaprone suture (Monocryl).
- Who it may be relevant to
- Registry conditions: Cesarean Delivery. Basic parameters: 18 years — 44 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post-Operative Cosmesis and Skin Closure Methods After Cesarean Section
Overview
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.
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.
Interventions
- Procedure absorbable subcuticular polyglycolic acid staples (INSORB)
Insorb absorbable staples are used for skin closure - Procedure subcuticular, polyglecaprone suture (Monocryl)
Monocryl absorbable staples are used for skin closure
Primary outcome measures
- scar cosmetic score [Time frame: Week 6]
Secondary outcome measures (7)
- Number of Wound complications [Time frame: Week 6]
- length of hospital stay [Time frame: Week 6]
- amount of in-hospital intravenous opiate analgesic use [Time frame: Week 6]
- amount of in-hospital oral NSAID analgesic use [Time frame: Week 6]
- amount of in-hospital oral opiate analgesic use [Time frame: Week 6]
- patient rated subjective pain score [Time frame: Week 6]
- patient's overall satisfaction with cosmesis scores [Time frame: Week 6]
Eligibility criteria
Inclusion criteria
- Age 18-44
- Any race
- Any parity
- Scheduled cesarean section
- Neuraxial analgesia
Exclusion criteria
- Non-English Speaking
- Incarcerated
- Maternal Connective Tissue Disorder
- Systemic maternal steroid use
- Three prior cesarean deliveries
- Body Mass Index (BMI) >40
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Wake Forest University Health Sciences — Winston-Salem
Identifiers
NCT: NCT06412978 · IRB00109639