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Completed

NCT Number: NCT01211600

Cesarean Trial of Staples vs. Sutures

To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.

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Key information

Conditions

Cesarean Section Behavior Health Behavior Infections Pain Measurement Patient Satisfaction Treatment Adherence and Compliance Wound Complications Wound Infection

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale University, New Haven, Connecticut, United States

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About this study

Despite this large number of cesareans performed annually, there is a paucity of data to suggest which technique is superior for closure of the skin incision with regards to wound complications, including wound separation and infection. As the morbidity associated with a cesarean delivery is usually related to wound complications, especially infection, we feel that it is important to examine this outcome by comparing the current skin closure techniques: staples versus suture.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women undergoing cesarean delivery for pregnancy greater than 23 weeks gestation.

Exclusion criteria

  • Poorly controlled diabetes (defined as ≥ 50% of fasting or 2 hour postprandial glucose levels > 95 and 120 respectively within the week prior to delivery),
  • Vertical skin incisions
  • Chronic steroid use
  • Active lupus flare
  • HIV/AIDS
  • Current treatment for cancer or a history of radiation to the abdomen/pelvis
  • Current treatment with immunosuppressant medications secondary to history of transplantation
  • Emergency cesarean(precluding informed consent prior to surgery)
  • Lack of access to a phone
  • Allergy to suture or staple material

Treatment and study plan

Staples

Other

Interrupted Ethicon Staples

Other names: Closure Technique

Suture

Other

Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)

Other names: Closure Technique

Primary outcomes

  1. Number of Participants With Wound Complications

    Time frame: Within 6 weeks of postpartum

    The primary outcome is to evaluate the rate of wound complications for patients undergoing cesarean whose skin incision is closed with staples versus with suture.

    Wound complications included infection, hematoma, seroma, and separation and readmission for wound complication.

Secondary outcomes

  1. Patient Scar Assessment Scale Scores for Evaluation of Cosmesis

    Time frame: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.

    Patient evaluation of cosmesis of the cesarean incision based on closure method: staples vs sutures.

    Surgical scars were evaluated using Patient Scar Assessment Scale (PSAS). The PSAS evaluates six items: pain, itchiness, color, stiffness, thickness, and irregularity. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 6-60. Lower scores indicate closer resemblance to normal skin and are superior.

  2. Patient Satisfaction With Closure Method and Scar Appearance

    Time frame: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.

    Whether the patient's satisfaction with the incision differed based on closure method (staples vs sutures) using 10-point Likert scale on which 1 is completely dissatisfied and 10 is completely satisfied.

  3. Pain Perception

    Time frame: Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean

    Whether the patient's perception of pain associated with the incision differed based on closure method (staples vs sutures). Patients were asked to rate pain on a scale from 0 (no pain) to 10 (extreme pain) using a visual graph of facial expressions.

  4. Additional Provider Visits

    Time frame: Within 6 weeks postpartum

    Mean number of visits per participant (All wound visits, number of visits for women who were diagnosed with wound complications, number of visits for women who were not diagnosed with a wound complication).

  5. Number of Participants With Primary Versus Repeat Cesarean

    Time frame: At randomization.

    Randomization stratum - BMI (over/under 30) and Cesarean (primary or repeat)

  6. Intraoperative Trial Details - Duration of Operation and Skin Closure

    Time frame: Time of Cesarean

    Duration of operation: skin incision to skin closure Duration of skin closure: fascial closure to skin closure

  7. Intraoperative Trial Details - Closure of Subcutaneous Tissue

    Time frame: Time of Cesarean

    Number of participants requiring subcutaneous tissue closure

  8. Length of Hospital Stay

    Time frame: Immediate postpartum.

    Length of hospital stay (days)

  9. Number of Participants That Received Anticoagulation Within 24 Hours

    Time frame: Within 24 hours postpartum.

    Number of participants that received anticoagulation within 24 hours of procedure (preoperatively or postoperatively)

  10. Number of Participants Diagnosed With Endomyometritis

    Time frame: Immediate postpartum.

    Number of participants diagnosed with endomyometritis requiring antibiotics

  11. Change in Hemoglobin Pre-operatively to Post-operatively

    Time frame: Up to 72 hours before and 24 hours after cesarean.

    Median change in hemoglobin from preoperative value (g/dL) to post-operatively.

  12. Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures.

    Time frame: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.

    Surgical scars were evaluated using Observer Scar Assessment Scale (OSAS). The OSAS evaluates five items: vascularity, pigmentation, thickness, relief, and pliability. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 5-50. Lower scores indicate closer resemblance to normal skin and are superior.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Main Line Health

Registry information

Official study title

Cesarean Randomized Control Trial Of Sutures vs. Staples (CROSS)

Acronym: CROSS

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 29, 2010
Registry last updated
Nov 26, 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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