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

This study has been completed.
Sponsor:
Collaborator:
Kimberly-Clark Corporation
Information provided by:
Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT00829556
First received: January 26, 2009
Last updated: December 18, 2009
Last verified: December 2009
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
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: Skin Infections
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
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: Integuseal
No Intervention: 2
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:

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

Locations
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
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: Javad Parvizi, MD, FRCS, Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT00829556     History of Changes
Other Study ID Numbers: RIFJPAR 08-01
Study First Received: January 26, 2009
Last Updated: December 18, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Skin Diseases, Infectious
Arthritis, Infectious
Infection
Skin Diseases
 Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 21, 2013