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

Not Applicable

Completed

• Conditions: Pregnancy; Cesarean Section
• Interventions: Procedure: Prolene non-absorbable sutures; Procedure: Absorbable Sutures; Procedure: Staples

• Registration Number: NCT01509950
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-13
• Primary Completion: 2013-05-04
• Study Completion: 2013-05-04
• Status Verified: 2018-11
• Results First Submitted: 2018-11-01
• Results First Submitted QC: 2018-11-01
• Last Update Submitted: 2018-11-01
• Results First Posted: 2019-03-04
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prolene non-absorbable sutures	Prolene non-absorbable sutures	Use of Prolene non-absorbable sutures for skin closure at cesarean section
Absorbable sutures	Absorbable Sutures	Use of absorbable sutures for skin closure at cesarean section; monocryl or vicryl.
Staples	Staples	Use of staples for skin closure at cesarean section

Primary Outcome Measures

Name	Time	Method
Level of Pain on a Scale During the Post-operative Hospitalization Period	Post-operative day 3 or 4.	Pain level on a Mosby visual analog pain scale of 1 (no pain) to 10 (worst pain)

Secondary Outcome Measures

Name	Time	Method
Time From Skin Incision to the Skin Closure	Day of cesarean delivery (up to 8 hours)	Measured in minutes
Level of Pain on a Scale at 6 Weeks Postpartum	Post-operative week 6	Pain level on a scale (Mosby visual analog pain scale) of 1 (no pain) to 10 (worst pain).
Count of Participants With Wound Complications	Post-operative week 6	Wound complications include conditions like infection, seroma/hematoma and dehiscence
Level of Patient Satisfaction to the Wound Appearance	Post-operative day 3 or 4	Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)
Time Needed for the Suture Removal	Post-operative day 3 or 4	Measured in seconds
Level of Patient Satisfaction to the Wound Appearance at 6 Weeks Postpartum	Post-operative week 6	Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)
Level of Patient's Satisfaction to the Cosmesis of the Wound	Post-operative week 6	Measured on a scale of 0 (very unsatisfied to the cosmesis) to 10 (very satisfied to the cosmesis)
Level of Patient's Overall Patient Satisfaction to the Type of Closure	Post-operative week 6	Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)

Trial Locations

Locations (1)

Lucile Packard Childrens Hospital; 🇺🇸 Palo Alto, California, United States