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

Primary Purpose

Prosthetic Joint Infection, Surgical Skin Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integuseal
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prosthetic Joint Infection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rothman Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Standard Surgical skin preparation

Outcomes

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.

Secondary Outcome Measures

To evaluate the effect of using Integuseal on the length of hospital stay after THA or TKA.
To evaluate the effect of using Integuseal on the incidence of surgical site infection (SSI).
To evaluate the effect of using Integuseal on the incidence of revision or re-admission after undergoing THA or TKA

Full Information

First Posted
January 26, 2009
Last Updated
December 18, 2009
Sponsor
Rothman Institute Orthopaedics
Collaborators
Kimberly-Clark Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00829556
Brief Title
Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing Total Joint Replacement
Official Title
Single-Center, Randomized Trial to Study the Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rothman Institute Orthopaedics
Collaborators
Kimberly-Clark Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthetic Joint Infection, Surgical Skin Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
No Intervention
Arm Description
Standard Surgical skin preparation
Intervention Type
Device
Intervention Name(s)
Integuseal
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
To evaluate the effect of using Integuseal on the incidence of surgical site infection (SSI).
Time Frame
6 weeks
Title
To evaluate the effect of using Integuseal on the incidence of revision or re-admission after undergoing THA or TKA
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javad Parvizi, MD, FRCS
Organizational Affiliation
Rothman Institute Orthopaedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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