Efficacy of InteguSeal for Surgical Skin Preparation in P... | NCT00829556

Studies
Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing Total Joint Replacement

NCT00829556

Sponsor

Rothman Institute Orthopaedics

Status

Completed

Last Update Posted

Dec 21, 2009Estimated

Enrollment

160Estimated

Phase

Not Applicable

Conditions

Prosthetic Joint Infection
Surgical Skin Infection

Interventions

Integuseal

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

Dec 2009

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

Apr 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Jan 26, 2009

First Submission Date that Met QC Criteria

Jan 26, 2009

First Posted Date

Jan 27, 2009Estimated

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

Dec 18, 2009

Last Update Posted Date

Dec 21, 2009Estimated

Name	Class
Kimberly-Clark Corporation	INDUSTRY

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

This study is being conducted to investigate the potential benefits of using a special type of fluid that can be applied to the skin (Integuseal) in addition to standard surgical skin preparation in patients undergoing total hip replacement (THA) or total knee replacement (TKA). Integuseal is supposed to lock down the skin bacteria and reduce skin infection and other problems. This study will investigate whether Integuseal is effective in reducing persistent wound drainage when used in addition to standard surgical skin preparation for total hip arthroplasty (THA) or total knee replacement (TKA).

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Label	Type	Description	Intervention Names
1	Experimental		Device: Integuseal
2	No Intervention	Standard Surgical skin preparation

Name	Type	Description	Arm Group Labels	Other Names
Integuseal	Device		1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary endpoint of the study will be to determine the incidence of postoperative wound drainage during hospital stay when adding Integuseal to the normal surgical skin preparation.		Total joint replacement to discharge from hospital

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the effect of using Integuseal on the length of hospital stay after THA or TKA.		Total joint replacement to discharge from hospital
To evaluate the effect of using Integuseal on the incidence of surgical site infection (SSI).		6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who are able and willing to provide informed consent;
Male and non-pregnant, non-lactating, female subjects who are willing to practice effective means of contraception or postmenopausal/surgically sterilized female subjects, between the ages of 18-80 years old, of any ethnic origin.
Subjects deemed able to comply with study schedule visits, procedures and medications as specified by the protocol.
Subjects undergoing elective THA or TKA procedures.
Subjects in satisfactory health as determined by the investigator on the basis of medical history and physical examination.

Exclusion Criteria:

Subjects undergoing revision, hemiarthroplasty, or bilateral THA or TKA
Subjects undergoing non-elective THA or TKA procedures.
Pregnant or lactating females or females of childbearing potential not practicing an effective method of contraception.
Subjects with known allergies to iodine and/or chlorhexidine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Javad Parvizi, MD, FRCS	Rothman Institute Orthopaedics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rothman Institute		Philadelphia	Pennsylvania	19107	United States