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

Rothman Institute Orthopaedics

Status

Completed

Conditions

Prosthetic Joint Infection

Surgical Skin Infection

Treatments

Device: Integuseal

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00829556

RIFJPAR 08-01

Details and patient eligibility

About

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).

Enrollment

160 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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