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Completed

NCT Number: NCT01509950

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Childrens Hospital

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Staples

Procedure

Staples for closure of cesarean section skin incision

Other names: Reflex one skin stapler 35 wide. Manufactured by Conmed

Prolene non-absorbable sutures

Procedure

Prolene non-absorbable sutures for closure of cesarean skin incision

Other names: Prolene 2-0 18 inch on FS needle. Manufactured by Ethicon

Absorbable Sutures

Procedure

Absorbable sutures for closure of cesarean skin incision

Other names: Monocryl or Vicryl. Manufactured by Ethicon

Primary outcomes

  1. Level of Pain on a Scale During the Post-operative Hospitalization Period

    Time frame: Post-operative day 3 or 4.

    Pain level on a Mosby visual analog pain scale of 1 (no pain) to 10 (worst pain)

Secondary outcomes

  1. Level of Pain on a Scale at 6 Weeks Postpartum

    Time frame: Post-operative week 6

    Pain level on a scale (Mosby visual analog pain scale) of 1 (no pain) to 10 (worst pain).

  2. Count of Participants With Wound Complications

    Time frame: Post-operative week 6

    Wound complications include conditions like infection, seroma/hematoma and dehiscence

  3. Level of Patient Satisfaction to the Wound Appearance

    Time frame: Post-operative day 3 or 4

    Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)

  4. Level of Patient Satisfaction to the Wound Appearance at 6 Weeks Postpartum

    Time frame: Post-operative week 6

    Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)

  5. Time From Skin Incision to the Skin Closure

    Time frame: Day of cesarean delivery (up to 8 hours)

    Measured in minutes

  6. Time Needed for the Suture Removal

    Time frame: Post-operative day 3 or 4

    Measured in seconds

  7. Level of Patient's Satisfaction to the Cosmesis of the Wound

    Time frame: Post-operative week 6

    Measured on a scale of 0 (very unsatisfied to the cosmesis) to 10 (very satisfied to the cosmesis)

  8. Level of Patient's Overall Patient Satisfaction to the Type of Closure

    Time frame: Post-operative day 1

    Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)

  9. Level of Patient's Overall Patient Satisfaction to the Type of Closure

    Time frame: Post-operative day 3 or 4

    Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)

  10. Level of Patient's Overall Patient Satisfaction to the Type of Closure

    Time frame: Post-operative week 6

    Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Comparison of Staples Versus Nonabsorbable Subcuticular (Prolene) Suture for Skin Closure in Cesarean Deliveries: A Randomized Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 13, 2012
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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