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

December 18, 2009 updated by: Rothman Institute Orthopaedics

Single-Center, Randomized Trial to Study the Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Device: Integuseal
NO_INTERVENTION: 2
Standard Surgical skin preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Total joint replacement to discharge from hospital
Total joint replacement to discharge from hospital

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Total joint replacement to discharge from hospital
To evaluate the effect of using Integuseal on the incidence of surgical site infection (SSI).
Time Frame: 6 weeks
6 weeks
To evaluate the effect of using Integuseal on the incidence of revision or re-admission after undergoing THA or TKA
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Collaborators

Kimberly-Clark Corporation

Investigators

  • Principal Investigator: Javad Parvizi, MD, FRCS, Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

January 26, 2009

First Submitted That Met QC Criteria

January 26, 2009

First Posted (ESTIMATE)

January 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 21, 2009

Last Update Submitted That Met QC Criteria

December 18, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIFJPAR 08-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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