Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing Total Joint Replacement - Full Text View

Sponsors and Collaborators:	Rothman Institute Orthopaedics Kimberly-Clark Corporation
Information provided by:	Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:	NCT00829556

Purpose

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).

Condition	Intervention
Prosthetic Joint Infection Surgical Skin Infection	Device: Integuseal

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Single-Center, Randomized Trial to Study the Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing

Resource links provided by NLM:

MedlinePlus related topics: Surgery

U.S. FDA Resources

Further study details as provided by Rothman Institute Orthopaedics:

Primary Outcome Measures:

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. [ Time Frame: Total joint replacement to discharge from hospital ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the effect of using Integuseal on the length of hospital stay after THA or TKA. [ Time Frame: Total joint replacement to discharge from hospital ] [ Designated as safety issue: No ]
To evaluate the effect of using Integuseal on the incidence of surgical site infection (SSI). [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
To evaluate the effect of using Integuseal on the incidence of revision or re-admission after undergoing THA or TKA [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: Integuseal
2: No Intervention Standard Surgical skin preparation

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829556

Locations

United States, Pennsylvania
Rothman Institute	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Javad Parvizi, MD, FRCS 267-339-3572

Sponsors and Collaborators

Rothman Institute Orthopaedics

Kimberly-Clark Corporation

Investigators

Principal Investigator:

Javad Parvizi, MD, FRCS

Rothman Institute Orthopaedics

More Information

No publications provided

Responsible Party:	Rothman Institute Orthopaedics ( Javad Parvizi, MD, FRCS )
Study ID Numbers:	RIFJPAR 08-01
Study First Received:	January 26, 2009
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00829556 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Skin Diseases, Infectious
Skin Diseases

Additional relevant MeSH terms:

Communicable Diseases
Skin Diseases, Infectious
Skin Diseases
Infection

ClinicalTrials.gov processed this record on September 10, 2009