Clinical Trial: Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing Total Joint Replacement
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Single-Center, Randomized Trial to Study the Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing
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).
Detailed Summary:
Sponsor: Rothman Institute Orthopaedics
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
- To evaluate the effect of using Integuseal on the incidence of surgical site infection (SSI). [ Time Frame: 6 weeks ]
- To evaluate the effect of using Integuseal on the incidence of revision or re-admission after undergoing THA or TKA [ Time Frame: 6 weeks ]
Original Secondary Outcome: Same as current
Information By: Rothman Institute Orthopaedics
Dates:
Date Received: January 26, 2009
Date Started: April 2008
Date Completion:
Last Updated: December 18, 2009
Last Verified: December 2009
