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

NCT ID: NCT00829556

Last Updated: 2009-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-09-30

Brief Summary

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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

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Conditions

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Prosthetic Joint Infection Surgical Skin Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Integuseal

Intervention Type DEVICE

2

Standard Surgical skin preparation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Integuseal

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subjects who are able and willing to provide informed consent;
2. 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.
3. Subjects deemed able to comply with study schedule visits, procedures and medications as specified by the protocol.
4. Subjects undergoing elective THA or TKA procedures.
5. Subjects in satisfactory health as determined by the investigator on the basis of medical history and physical examination.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kimberly-Clark Corporation

INDUSTRY

Sponsor Role collaborator

Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Rothman Institute Orthopaedics

Principal Investigators

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Javad Parvizi, MD, FRCS

Role: PRINCIPAL_INVESTIGATOR

Rothman Institute Orthopaedics

Locations

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Rothman Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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RIFJPAR 08-01

Identifier Type: -

Identifier Source: org_study_id