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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00829556

Enrollment

160

Registered

2009-01-27

Start date

2008-04-30

Completion date

2009-09-30

Last updated

2009-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthetic Joint Infection, Surgical Skin Infection

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).

Interventions

DEVICEInteguseal

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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.	Total joint replacement to discharge from hospital

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026