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

Prosthetic Joint Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829556
• Other study ID #: RIFJPAR 08-01
• Status: Completed
• Phase: N/A
• First received: January 26, 2009
• Last updated: December 18, 2009
• Start date: April 2008
• Est. completion date: September 2009

Study information

• Verified date: December 2009
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Prosthetic Joint Infection
• Skin Diseases, Infectious
• Surgical Skin Infection

Intervention

Device:
• Integuseal

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics	Kimberly-Clark Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Total joint replacement to discharge from hospital	Yes
Secondary	To evaluate the effect of using Integuseal on the length of hospital stay after THA or TKA.		Total joint replacement to discharge from hospital	No
Secondary	To evaluate the effect of using Integuseal on the incidence of surgical site infection (SSI).		6 weeks	Yes
Secondary	To evaluate the effect of using Integuseal on the incidence of revision or re-admission after undergoing THA or TKA		6 weeks	No