A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement

January 4, 2018 updated by: Orthopaedic Research Foundation
The purpose of this study is to compare the use of INSORB absorbable staples with metal staples on surgical incision healing after total hip replacement. The study evaluates wound healing, complications, and patient satisfaction regarding wound comfort and appearance after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subcuticular closure of wounds can provide superior results to percutaneous suture closure due to the elimination of suture or staple tracts. These tracts can lead to infection and migration of epithelial cells adding to scarring, and cross-hatching scars which remain after healing. Absorbable staples can provide a rapid, secure, subcuticular closure of skin as an alternative to the traditional, manual staple or suture closure. This study will compare INSORB absorbable staples to externally applied standard metal staples with respect to effectiveness of incision closure, acute healing, subject comfort level, security and appearance after total hip replacement.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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
    • Indiana
      • Indianapolis, Indiana, United States, 46278
        • Indiana Orthopaedic 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

All

Description

Inclusion Criteria:

  • Patient is 18 years or older
  • Patient or legal representative is able to understand and provide signed consent for the procedure
  • Patient is willing and able to return for required follow-up visits
  • Patient needs a total hip arthroplasty surgical procedure

Exclusion Criteria:

  • Patient has an active infection
  • Patient is enrolled in another similar study
  • Patient has a known history of hepatitis
  • Patient has a known history of HIV
  • Patient has a known history of AIDs
  • Patient has a known history of IV drug abuse

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insorb staples
Subcuticular Absorbable staples
Device: Insorb staples
absorbable staples required for wound closure
Other Names:
  • Insorb absorbable stapler
  • GDW
Active Comparator: Control
Metal staple wound closure
Device: metal staples (Ethicon metal stapler)
wound closure with metal staples
Other Names:
  • Ethicon metal stapler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants With Incisional Drainage, Swelling or Gaps of Incision
Time Frame: Discharge from initial hospital stay (2-5 days post-op)
Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters.
Discharge from initial hospital stay (2-5 days post-op)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants With Wound Complications - Hematoma
Time Frame: up to 6 weeks post-op
Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not.
up to 6 weeks post-op

Collaborators and Investigators

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

Sponsor

Orthopaedic Research Foundation

Collaborators

OrthoIndy

Investigators

  • Principal Investigator: David A Fisher, MD, Indiana Orthopaedic Hospital

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, 2007

Primary Completion (Actual)

April 30, 2010

Study Completion (Actual)

April 30, 2010

Study Registration Dates

First Submitted

July 14, 2009

First Submitted That Met QC Criteria

July 15, 2009

First Posted (Estimate)

July 16, 2009

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAF_PC000001

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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