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Completed

NCT Number: NCT00829556

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

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).

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Key information

Conditions

Prosthetic Joint Infection Surgical Skin Infection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integuseal

Device

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.

    Time frame: Total joint replacement to discharge from hospital

Secondary outcomes

  1. 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

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

    Time frame: 6 weeks

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

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Collaborators

  • Kimberly-Clark Corporation

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 27, 2009
Registry last updated
Dec 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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