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

NCT00829556 | Completed

• 1 other identifier: RIFJPAR 08-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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).

Conditions

Prosthetic Joint Infection; Surgical Skin Infection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• To evaluate the effect of using Integuseal on the length of hospital stay after THA or TKA.

  Total joint replacement to discharge from hospital

• To evaluate the effect of using Integuseal on the incidence of surgical site infection (SSI).

  6 weeks

• To evaluate the effect of using Integuseal on the incidence of revision or re-admission after undergoing THA or TKA

  6 weeks

Study Arms (2)

1

EXPERIMENTAL

Device: Integuseal

2

NO INTERVENTION

Standard Surgical skin preparation

Interventions

Integuseal DEVICE

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead
• Kimberly-Clark Corporation: collaborator

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Study Officials

• Javad Parvizi, MD, FRCS

  Rothman Institute Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 27, 2009
• Study Start: April 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: December 21, 2009

Record last verified: 2009-12

Locations

US (1)