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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01509950
Recruitment Status : Recruiting
First Posted : January 13, 2012
Last Update Posted : October 17, 2016
Information provided by (Responsible Party):
Natali Aziz, 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.

Condition or disease Intervention/treatment Phase
Pregnancy Cesarean Section Procedure: Staples Procedure: Prolene non-absorbable sutures Procedure: Absorbable Sutures Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Staples Versus Nonabsorbable Subcuticular (Prolene) Suture for Skin Closure in Cesarean Deliveries: A Randomized Study
Study Start Date : January 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
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

Active Comparator: Absorbable sutures
Use of absorbable sutures for skin closure at cesarean section; monocryl or vicryl.
Procedure: Absorbable Sutures
Absorbable sutures for closure of cesarean skin incision
Other Name: Monocryl or Vicryl. Manufactured by Ethicon

Primary Outcome Measures :
  1. Pain levels during the post-operative hospitalization period and at time of staple or suture removal. [ Time Frame: Third to fourth post operative day. ]

Secondary Outcome Measures :
  1. Pain at 6 weeks post op [ Time Frame: 6 weeks post op ]
  2. Wound complications (infection, seroma/hematoma, dehiscence) [ Time Frame: 6 weeks post op ]
  3. Patient satisfaction at post operative day 3, 4 and 6 weeks [ Time Frame: 6 weeks post op ]
  4. Operative room time [ Time Frame: Time of skin incision to time of skin closure ]
  5. Removal time [ Time Frame: Post operative day 3 or 4 ]
  6. Overall cosmesis [ Time Frame: 6 weeks post op ]
    A zero to 5 scale cosmesis score. Zero being worst and 5 being best appearance.

  7. Overall patient satisfaction [ Time Frame: 6 weeks post op ]
    Patient questionnaires completed at post op day 1, post op day 3 or 4 and 6 weeks post partum.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01509950

Contact: Natali Aziz, MD 650-724-8222
Contact: Anna Girsen, PhD 650-725-5720

United States, California
Lucile Packard Childrens Hospital Recruiting
Palo Alto, California, United States, 94304
Contact: Natali Aziz, MD    650-724-8222   
Sponsors and Collaborators
Stanford University
Principal Investigator: Natali Aziz, MD Stanford University

Responsible Party: Natali Aziz, Clinical Assistant Professor, Stanford University Identifier: NCT01509950     History of Changes
Other Study ID Numbers: 22389
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No