Study of Sutures Versus Staples for Skin Closure After Surgical Procedures of Hip

July 30, 2013 updated by: University of Kentucky

A Comparative Randomized Efficacy Study of Sutures Versus Staples in Hip Surgical Procedures

Skin closure either by sutures or staples is required after any surgical procedure of the hip.

The purpose of this study is to compare the amount of drainage between patients who have had either staples or sutures placed for skin closure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Skin closure either by sutures or staples is required after any surgical procedure of the hip.

The purpose of this study is to compare the amount of drainage between patients who have had either staples or sutures placed for skin closure.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 4

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
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center

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:

  • The patient must be 18 years of age or greater
  • The patient must need an operative procedure of hip

Exclusion Criteria:

  • Patients who are unable to undergo surgery.
  • Patients who have a history of clotting or bleeding abnormalities.
  • Patients who have arthroscopic hip surgery.
  • Patients who have infections.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Staples
Procedure: Surgical wound closure techniques
Subjects will be randomized to either receive sutures or staples during the surical procedure to close the incision
Procedure: Surgical wound closure techniques (Comparator)
Subjects will be randomized to either receive sutures or staples during the surical procedure to close the incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of drainage from skin closure site
Time Frame: up to 5 days following surgery
up to 5 days following surgery

Collaborators and Investigators

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

Sponsor

University of Kentucky

Investigators

  • Principal Investigator: Jeffrey Selby, MD, University of Kentucky Department of Orthopaedic Surgery

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

December 1, 2005

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

January 5, 2006

First Submitted That Met QC Criteria

January 5, 2006

First Posted (Estimate)

January 9, 2006

Study Record Updates

Last Update Posted (Estimate)

July 31, 2013

Last Update Submitted That Met QC Criteria

July 30, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 05-0715-F2L

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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