NCT00273715

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for phase_4 surgery

Timeline
Completed

Started Dec 2005

Typical duration for phase_4 surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

Enrollment Period

2.8 years

First QC Date

January 5, 2006

Last Update Submit

July 30, 2013

Conditions

Surgery

Keywords

ComparativeRandomizedSutureStaples, surgicalSkinSurgical procedures, operativeOrthopedicsJoint, hipSurgical procedures of Hip, Operative

Outcome Measures

Primary Outcomes (1)

  • Amount of drainage from skin closure site

    up to 5 days following surgery

Study Arms (1)

Staples

NO INTERVENTION
Procedure: Surgical wound closure techniquesProcedure: Surgical wound closure techniques (Comparator)

Interventions

Surgical wound closure techniquesPROCEDURE

Subjects will be randomized to either receive sutures or staples during the surical procedure to close the incision

Staples
Surgical wound closure techniques (Comparator)PROCEDURE

Subjects will be randomized to either receive sutures or staples during the surical procedure to close the incision

Staples

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Interventions

Wound Closure Techniques

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Jeffrey Selby, MD

    University of Kentucky Department of Orthopaedic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2006

First Posted

January 9, 2006

Study Start

December 1, 2005

Primary Completion

September 1, 2008

Study Completion

October 1, 2008

Last Updated

July 31, 2013

Record last verified: 2013-07

Locations

US(1)