Comparison of Staples Versus Prolene Suture for Skin Closure at Cesarean Delivery

Trial ID or NCT#

NCT01509950

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Comparison of Staples Versus Nonabsorbable Subcuticular (Prolene) Suture for Skin Closure in Cesarean Deliveries: A Randomized Study

Eligibility Criteria

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Natali Aziz, M.D., M.S.
Natali Aziz, M.D., M.S.
Obstetrician and Gynecologist (OB-GYN)
Clinical Associate Professor, Obstetrics & Gynecology - Maternal Fetal Medicine

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Contact

Natali Aziz, MD
650-724-8222