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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00273715
First received: January 5, 2006
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Surgery
Procedure: Surgical wound closure techniques
Procedure: Surgical wound closure techniques (Comparator)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Randomized Efficacy Study of Sutures Versus Staples in Hip Surgical Procedures

Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Amount of drainage from skin closure site [ Time Frame: up to 5 days following surgery ] [ Designated as safety issue: Yes ]

Enrollment: 93
Study Start Date: December 2005
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00273715

Locations
United States, Kentucky
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
Investigators
Principal Investigator: Jeffrey Selby, MD University of Kentucky Department of Orthopaedic Surgery
  More Information

No publications provided

Responsible Party: University of Kentucky
ClinicalTrials.gov Identifier: NCT00273715     History of Changes
Other Study ID Numbers: 05-0715-F2L
Study First Received: January 5, 2006
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Kentucky:
Comparative
Randomized
Suture
Staples, surgical
Skin
Surgical procedures, operative
Orthopedics
Joint, hip
Surgical procedures of Hip, Operative

ClinicalTrials.gov processed this record on October 16, 2014