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

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ClinicalTrials.gov Identifier: NCT01198691
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : June 12, 2014
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cesarean Section Device: Insorb absorbable staples Device: Insorb Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Closure of Pfannenstiel Skin Incisions After Cesarean Delivery: A Comparison of Metallic Staples Versus Absorbable Staples
Study Start Date : July 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control Group
This group will receive the standard metallic staples to close their incision.
 Device: Insorb absorbable staples
Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples
Experimental: Case Group
This group will receive the Insorb absorbable staples to close their incision.
 Device: Insorb
Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01198691


Locations
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United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
More Information
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Publications of Results:

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Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT01198691    
Other Study ID Numbers: 10018-10-016
First Posted: September 10, 2010    Key Record Dates
Results First Posted: June 12, 2014
Last Update Posted: October 9, 2018
Last Verified: May 2014
Keywords provided by TriHealth Inc.:
metallic staples
absorbable staples
Cesarean Delivery