Pregnancy
Conditions
Brief summary
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
Detailed description
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.
Interventions
PROCEDURESubcuticular monocryl suture
Under the skin suture placed by hand
DEVICESubcuticular absorbable staple using Insorb device
Under the skin stapling device that delivers absorbable staples
Sponsors
Inova Health Care Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 18-50 years of age * Women ≥ 24 weeks viable gestation * Will be undergoing cesarean delivery
Exclusion criteria
* Patient unwilling or unable to provide consent. * No or very limited prenatal care or a non-resident patient who is unlikely to follow-up after delivery. * Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 \<200, or other * Decision not to have skin closure (e.g. secondary wound closure, mesh closure) * Current skin infection * Coagulopathy * High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, tubal ligation, bowel or adnexal surgery) * Incarcerated individuals * Intraamniotic infection * Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operating time | Time from the start of surgery through end of skin closure up to 8 hours | Total time for the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Cosmesis | Up to six weeks post partum | 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. |
| Post Operative Pain | up to 3 days post-operatively | 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. |
Countries
United States
Contacts
CONTACTAntonio Saad, MD
CONTACTMichelle L Cassidy, PhD, RN
PRINCIPAL_INVESTIGATORAntonio Saad, MD
Inova Fairfax Medical Center
Outcome results
None listed