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

NCT ID: NCT01509950

Last Updated: 2019-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-05-04

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.

Conditions

Pregnancy; Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Staples

Use of staples for skin closure at cesarean section

Group Type: ACTIVE_COMPARATOR

Staples

Intervention Type: PROCEDURE

Staples for closure of cesarean section skin incision

Prolene non-absorbable sutures

Use of Prolene non-absorbable sutures for skin closure at cesarean section

Group Type: ACTIVE_COMPARATOR

Prolene non-absorbable sutures

Intervention Type: PROCEDURE

Prolene non-absorbable sutures for closure of cesarean skin incision

Absorbable sutures

Use of absorbable sutures for skin closure at cesarean section; monocryl or vicryl.

Group Type: ACTIVE_COMPARATOR

Absorbable Sutures

Intervention Type: PROCEDURE

Absorbable sutures for closure of cesarean skin incision

Interventions

Staples

Staples for closure of cesarean section skin incision

Intervention Type: PROCEDURE

Prolene non-absorbable sutures

Prolene non-absorbable sutures for closure of cesarean skin incision

Intervention Type: PROCEDURE

Absorbable Sutures

Absorbable sutures for closure of cesarean skin incision

Intervention Type: PROCEDURE

Other Intervention Names

Reflex one skin stapler 35 wide. Manufactured by Conmed; Prolene 2-0 18 inch on FS needle. Manufactured by Ethicon; Monocryl or Vicryl. Manufactured by Ethicon

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Natali Aziz

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Natali Aziz, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Lucile Packard Childrens Hospital

Palo Alto, California, United States

Countries

United States

Other Identifiers

22389

Identifier Type: -

Identifier Source: org_study_id