Study of Sutures Versus Staples for Skin Closure After Su... | NCT00273715

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

NCT00273715

Sponsor

University of Kentucky

Status

Completed

Last Update Posted

Jul 31, 2013Estimated

Enrollment

93Actual

Phase

Phase 4

Conditions

Surgery

Interventions

Surgical wound closure techniques
Surgical wound closure techniques (Comparator)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Sep 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Jan 5, 2006

First Submission Date that Met QC Criteria

Jan 5, 2006

First Posted Date

Jan 9, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2013

Last Update Posted Date

Jul 31, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

93Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Staples	No Intervention		Procedure: Surgical wound closure techniques Procedure: Surgical wound closure techniques (Comparator)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical wound closure techniques	Procedure	Subjects will be randomized to either receive sutures or staples during the surical procedure to close the incision	Staples

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey Selby, MD	University of Kentucky Department of Orthopaedic Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kentucky Chandler Medical Center		Lexington	Kentucky	40536	United States

Intervention Browse Module

MeSH Terms

ID	Term
D058106	Wound Closure Techniques

Ancestor Terms

ID	Term
D013514	Surgical Procedures, Operative

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Browse Branches

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