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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01509950
First received: January 5, 2012
Last updated: June 13, 2013
Last verified: June 2013
  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 and 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.


Condition Intervention Phase
Pregnancy
Cesarean Section
Procedure: Staples
Procedure: Prolene non-absorbable sutures
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Staples Versus Nonabsorbable Subcuticular (Prolene) Suture for Skin Closure in Cesarean Deliveries: A Randomized Study

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Pain levels during the post-operative hospitalization period and at time of staple or suture removal. [ Time Frame: Third to fourth post operative day. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain at 6 weeks post op [ Time Frame: 6 weeks post op ] [ Designated as safety issue: No ]
  • Wound complications (infection, seroma/hematoma, dehiscence) [ Time Frame: 6 weeks post op ] [ Designated as safety issue: No ]
  • Patient satisfaction at post operative day 3, 4 and 6 weeks [ Time Frame: 6 weeks post op ] [ Designated as safety issue: No ]
  • Operative room time [ Time Frame: Time of skin incision to time of skin closure ] [ Designated as safety issue: No ]
  • Removal time [ Time Frame: Post operative day 3 or 4 ] [ Designated as safety issue: No ]
  • Overall cosmesis [ Time Frame: 6 weeks post op ] [ Designated as safety issue: No ]
    A zero to 5 scale cosmesis score. Zero being worst and 5 being best appearance.

  • Overall patient satisfaction [ Time Frame: 6 weeks post op ] [ Designated as safety issue: No ]
    Patient questionnaires completed at post op day 1, post op day 3 or 4 and 6 weeks post partum.


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Staples
Use of staples for skin closure at cesarean section
Procedure: Staples
Staples for closure of cesarean section skin incision
Other Name: Reflex one skin stapler 35 wide. Manufactured by Conmed
Active Comparator: Prolene non-absorbable sutures
Use of Prolene non-absorbable sutures for skin closure at cesarean section
Procedure: Prolene non-absorbable sutures
Prolene non-absorbable sutures for closure of cesarean skin incision
Other Name: Prolene 2-0 18 inch on FS needle. Manufactured by Ethicon

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). 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. Both patients 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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509950

Contacts
Contact: Natali Aziz, MD 650-724-8222 naziz@stanford.edu
Contact: Maggi Baumbusch, MD 650-225-8623 mbaumbus@stanford.edu

Locations
United States, California
Lucile Packard Childrens Hospital Recruiting
Palo Alto, California, United States, 94304
Contact: Natali Aziz, MD    650-724-8222    naziz@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Natali Aziz, MD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01509950     History of Changes
Other Study ID Numbers: 22389
Study First Received: January 5, 2012
Last Updated: June 13, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 23, 2014