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

January 5, 2012
June 13, 2013
January 2012
January 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01509950 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Comparison of Staples Versus Prolene Suture for Skin Closure at Cesarean Delivery
Comparison of Staples Versus Nonabsorbable Subcuticular (Prolene) Suture for Skin Closure in Cesarean Deliveries: A Randomized Study

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pregnancy
  • Cesarean Section
  • Procedure: Staples
    Staples for closure of cesarean section skin incision
    Other Name: Reflex one skin stapler 35 wide. Manufactured by Conmed
  • 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
  • Active Comparator: Staples
    Use of staples for skin closure at cesarean section
    Intervention: Procedure: Staples
  • Active Comparator: Prolene non-absorbable sutures
    Use of Prolene non-absorbable sutures for skin closure at cesarean section
    Intervention: Procedure: Prolene non-absorbable sutures
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2015
January 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 55 Years
No
Contact: Natali Aziz, MD 650-724-8222 naziz@stanford.edu
Contact: Maggi Baumbusch, MD 650-225-8623 mbaumbus@stanford.edu
United States
 
NCT01509950
22389
No
Stanford University
Stanford University
Not Provided
Principal Investigator: Natali Aziz, MD Stanford University
Stanford University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP