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Completed

NCT Number: NCT02466776

Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery

The purpose of this study is to determine the optimal skin closure technique (staples versus subcuticular suture) at the time of cesarean delivery in Class III obese women with body mass index (BMI) of >/= 40kg/m2.

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Key information

Conditions

Obesity, Severe Body Weight Cesarean Section Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Long Beach Memorial Care Center, Long Beach, California, United States

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About this study

A. To assess the rate of wound complications with staples versus subcuticular suture closure in women with a BMI of ≥ 40 kg/m2 undergoing cesarean delivery (CD).

B. No difference was observed in wound complication rates between staples and subcuticular suture skin closure in women with a BMI ≥ 40 kg/m2 undergoing cesarean delivery (CD).

C. At this time, optimal skin closure method in obese women with BMI ≥ 40 kg/m2 undergoing cesarean delivery remains unknown. More work is needed in this area to help reduce the complication rate in this very high-risk population.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women > 18 years old undergoing cesarean delivery (CD)
  • BMI of >/= 40 kg/m2 as determined by height and weight reported during their admission
  • Live gestation 23 weeks or greater
  • Women who are able to follow-up 7-14 days after hospital discharge for a visual wound check.

Exclusion criteria

  • Active lupus flare
  • HIV/AIDS
  • Current treatment for cancer or h/o radiation to the abdomen/pelvis
  • Hypersensitivity to steri-strips

Treatment and study plan

Absorbable subcuticular suture

Device

Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).

Other names: 3-0 monocryl

Stainless steel staples

Device

Patients will receive stainless steel staples for skin closure at time of cesarean delivery (CD).

Other names: Staples

Primary outcomes

  1. Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum

    Time frame: At hospital discharge, at 2 weeks postpartum and at 6 weeks postpartum

    Rate of wound complications defined as composite wound complication, which includes infection requiring antibiotics, hematoma, seroma, separation or disruption, and/or readmission to the hospital for wound concerns.

Secondary outcomes

  1. Number of Participants According to Skin Incision

    Time frame: At time of surgery and hospitalization

    Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable

  2. Operating Surgeon Level

    Time frame: At time of surgery

    Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable

  3. Surgical Assistant Level

    Time frame: At time of surgery

    Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable

  4. Total Operative Time

    Time frame: At time of surgery and hospitalization

    Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable

  5. Total Blood Loss

    Time frame: At time of surgery

    Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable

  6. Number of Participants With Blood Transfusion

    Time frame: At time of surgery and hospitalization

    Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable

  7. Change in Hemoglobin (Pre-delivery and Post-delivery)

    Time frame: At time of surgery (pre-delivery) and post-delivery

    Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable

  8. Neonatal Birthweight

    Time frame: At time of delivery

    Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable

  9. Number of Participants With 5 Minute Apgar Score <7

    Time frame: At time of delivery

    Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable The Apgar score, developed by Virginia Apgar describes the condition of the newborn infant immediately after birth and, when properly applied, is a tool for standardized assessment 18. It also provides a mechanism to record fetal-to-neonatal transition. This scoring system provided a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The Apgar score ranges from 0 (lowest, poor outcome) to 10 (highest, good outcome).

  10. Number of Participants Receiving Postpartum Prophylactic Anticoagulation

    Time frame: During hospitalization

    Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable

  11. Total Length of Hospital Stay

    Time frame: At time of surgery and hospitalization

    Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable

  12. Patient Pain Score (From 1 to 10)

    Time frame: Within 2 weeks postpartum

    Patients' pain associated with their wound within 7-14 days after hospital discharge using a self-administered questionnaire that asked patients to rate their pain on a scale of 0 (no pain) to 10 (worst pain).

  13. Patient Satisfaction With Wound Healing and Appearance

    Time frame: At time of hospital discharge and at 2 weeks postpartum

    Patients' satisfaction with the healing of their wound within 7-14 days after hospital discharge using a self-administered questionnaire that asked patients to rate their overall satisfaction with their wound healing and appearance (1=least satisfied, 10=most satisfied). Patients were also asked to rate their concern regarding their wound healing (1= least concerned and 10 = most concerned).

Sponsors and collaborators

Lead sponsor

MemorialCare Health System

Other

Collaborators

  • University of California, Irvine

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 9, 2015
Registry last updated
Jan 9, 2024

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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