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

September 10, 2018 updated by: TriHealth Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 Year
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.
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
This will be assessed 3 day after the patient's C-section before they are discharged from the hospital
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.
Patient satisfaction will be assessed 6 weeks later at their post-op visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriHealth Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 2, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10018-10-016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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