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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT01198691
First received: September 2, 2010
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Cesarean Section
Device: Insorb absorbable staples
Device: Insorb
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Closure of Pfannenstiel Skin Incisions After Cesarean Delivery: A Comparison of Metallic Staples Versus Absorbable Staples

Resource links provided by NLM:


Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • Post Operative Pain [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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.

  • Post Operative Pain (3 Days Post-op) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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:
  • Patient Satisfaction [ Time Frame: This will be assessed 3 day after the patient's C-section before they are discharged from the hospital ] [ Designated as safety issue: No ]
    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.

  • Patient Satisfaction [ Time Frame: Patient satisfaction will be assessed 6 weeks later at their post-op visit ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: July 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198691

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

Publications:
Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT01198691     History of Changes
Other Study ID Numbers: 10018-10-016
Study First Received: September 2, 2010
Results First Received: March 13, 2014
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by TriHealth Inc.:
metallic staples
absorbable staples
Cesarean Delivery

ClinicalTrials.gov processed this record on September 18, 2014