Comparison of Staples Versus Prolene Suture for Skin Closure at Cesarean Delivery
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Details and patient eligibility
About
Currently different materials are used to close the skin after a cesarean delivery, including absorbable suture, non-absorbable suture and staples. It is not known what is the best choice of material to close the skin after a cesarean section, but commonly staples or dissolvable suture is used. Recently plastic surgeons have found that non-dissolvable suture may have a better cosmetic outcome than staples. The investigators hope to learn if there is a difference in pain both at suture/staple removal and 6 weeks postoperatively between Prolene suture, Absorbable suture (monocryl or vicryl) or staples. The investigators also plan to look for differences in wound complications and patient satisfaction, as well as operating and removal times. This knowledge will be important in helping practitioners choose the closure technique at cesarean delivery.
Full description
Patients who meet inclusion criteria will be approached upon admission to Labor and Delivery. A study staff member will describe the study and offer participation. If a patient agrees to participate, she will sign research protocol and HIPAA consent forms and receive a copy of these forms. The patient's chart will be flagged, indicating that she is a study participant. The patient's prenatal care and labor and delivery will be managed by her physician per standard of care at the physician's discretion, including routine surgical preparation and procedures.
When a participating patient is scheduled for a cesarean section, she will be randomized to Arm 1 (Staples) or Arm 2 (Prolene) or Arm 3 (Monocryl or Vicryl absorbable suture). She will be treated as per standard of care and her cesarean section performed per physician discretion. After the closure of the fascial layer, the surgeons will follow the same protocol for each study participant, including wound irrigation with warm sterile saline and reapproximation of the subcutaneous layer if greater than 2.0 cm in depth (per standard of care). The patient in Arm 1 will have skin closure with staples. The patient in Arm 2 will have skin closure with 2-0 Prolene in a subcuticular fashion. The patient in Arm 3 will have skin closure with monocryl or vicryl in the standard fashion. Patients in Arms 1 and 2 will have their closure material removed at the physician's discretion per the standard of care at post-operative day 3 or 4.
Pain level will be assessed on the first and third or fourth day after surgery and again at six weeks.
Enrollment
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Volunteers
Inclusion criteria
- Pregnant women undergoing primary or repeat cesarean section
- Maternal age greater than or equal to 18 years of age
- Gestational age greater than or equal to 34 weeks
- Elective and non-elective cesarean section
Exclusion criteria
- Type 1 or Type 2 diabetes
- BMI greater than 35
- Pre-operative diagnosis of chorioamnionitis
- History of drug or alcohol abuse
- Contraindication to NSAIDs
- Chronic pain diagnosis
- Narcotic use prior to pregnancy
- Maternal age less than 18 years of age
- General anesthesia
- Chorioamnionitis, clinical suspicion of chorioamnionitis, or risk factors for chorioamnionitis (membrane rupture greater than 18 hours, GBS positive status)
- Vertical skin incision
Trial design
Primary purpose
Allocation
Interventional model
Masking
15 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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