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Completed

NCT Number: NCT01198691

A Comparison of Metallic Staples Versus Absorbable Staples After a Cesarean Section (C-Section)

The purpose of the study is to compare post operative pain, cost effectiveness, speed of closure and patient satisfaction of Pfannenstiel incisions closed with metallic staples versus absorbable staples (Insorb) after Cesarean Delivery.

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Key information

Conditions

Cesarean Section

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

About this study

The ideal method of closing the skin following a Pfannenstiel incision has not yet been established. Presently, the method of skin closure is a matter of the surgeon's personal preference. Currently, there is limited evidence regarding which method is considered "superior" in terms of post operative pain, patient satisfaction, and cost effectiveness. This information would be incredibly valuable in helping guide surgeons in their choice of skin closure technique; and with the rates of Cesarean deliveries rapidly rising, it is important to determine the best method of skin closure in order to optimize patient care.

After a patient is consented she will be randomized into either the control group and receive the standard metallic staples or the experimental group and receive the absorbable staples for her skin closure procedure. One day after her procedure the RN will ask the patient to rate her pain using a 10cm VAS pain scale. Two or three days after the skin closure and before the patient is discharged a short survey about the patient's satisfaction of her scar appearance will be administered. The PI will go back and review the patient's chart to determine the amount of narcotics administered.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Obstetric service patients (receiving prenatal care from the Faculty Medical Center)
  • Women greater than 18 years old
  • Singleton gestation
  • Cesarean Section performed by Pfannenstiel skin incision

Exclusion criteria

  • History of drug or alcohol abuse
  • Contraindication to post operative NSAID's or Narcotics
  • Emergent Cesarean Deliveries
  • Less then 18 years of age

Treatment and study plan

Insorb absorbable staples

Device

Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples

INSORB

Device

Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples

Primary outcomes

  1. Post Operative Pain

    Time frame: 1 Year

    Post operative pain at post operative day #1 will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.

  2. Post Operative Pain (3 Days Post-op)

    Time frame: 1 Year

    Post operative pain at the time of discharge will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.

Secondary outcomes

  1. Patient Satisfaction

    Time frame: This will be assessed 3 day after the patient's C-section before they are discharged from the hospital

    Patients will be given a survey prior to being discharged to assess their satisfaction with the appearance of their scar. The survey asked whether patients "strongly agree," "agree," "disagree," or "strongly disagree" with the statement, "I am satisfied with the overall appearance of my incision." Those who responsed "agree" or "strongly agree" were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied.

  2. Patient Satisfaction

    Time frame: Patient satisfaction will be assessed 6 weeks later at their post-op visit

    Patients will be given a survey at their 6 week post-op visit to assess their satisfaction with the appearance of their scar. The survey asked whether patients "strongly agree," "agree," "disagree," or "strongly disagree" with the statement, "I am satisfied with the overall appearance of my incision." Those who responsed "agree" or "strongly agree" were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied.

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

Closure of Pfannenstiel Skin Incisions After Cesarean Delivery: A Comparison of Metallic Staples Versus Absorbable Staples

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 10, 2010
Registry last updated
Oct 9, 2018

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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