Clinical trial NCT01509950: Comparison of Staples Versus Prolene Suture for Skin Closure at Cesarean Delivery
Official title: Comparison of Staples Versus Nonabsorbable Subcuticular (Prolene) Suture for Skin Closure in Cesarean Deliveries: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Cesarean Section
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of Pain on a Scale During the Post-operative Hospitalization Period
timeFrame: Post-operative day 3 or 4.
Secondary outcomes:
measure: Level of Pain on a Scale at 6 Weeks Postpartum
timeFrame: Post-operative week 6
measure: Count of Participants With Wound Complications
timeFrame: Post-operative week 6
measure: Level of Patient Satisfaction to the Wound Appearance
timeFrame: Post-operative day 3 or 4
measure: Level of Patient Satisfaction to the Wound Appearance at 6 Weeks Postpartum
timeFrame: Post-operative week 6
measure: Time From Skin Incision to the Skin Closure
timeFrame: Day of cesarean delivery (up to 8 hours)
measure: Time Needed for the Suture Removal
timeFrame: Post-operative day 3 or 4
measure: Level of Patient's Satisfaction to the Cosmesis of the Wound
timeFrame: Post-operative week 6
measure: Level of Patient's Overall Patient Satisfaction to the Type of Closure
timeFrame: Post-operative day 1
measure: Level of Patient's Overall Patient Satisfaction to the Type of Closure
timeFrame: Post-operative day 3 or 4
measure: Level of Patient's Overall Patient Satisfaction to the Type of Closure
timeFrame: Post-operative week 6
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Childrens Hospital
state: California
Study officials:
affiliation: Stanford University
name: Natali Aziz, MD
role: PRINCIPAL_INVESTIGATOR
References: