Evaluating the Effectiveness of 2 Surgical Skin Preparation Methods in Reducing Surgical Wound Drainage After Total Hip or Knee Replacement

This study is currently recruiting participants.

Verified November 2011 by Rothman Institute Orthopaedics

Sponsor:

Collaborator:

Information provided by:

Rothman Institute Orthopaedics

ClinicalTrials.gov Identifier:

NCT01097135

First received: March 30, 2010

Last updated: November 7, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 30, 2010

Last Updated Date

November 7, 2011

Start Date ^ICMJE

March 2010

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary objective of this study is to determine the rate of wound drainage following total joint arthroplasty (TJA) until discharge in both treatment groups

Starting on post operative day 1 (the first day following surgery), at the time of the surgical dressings are removed and changed, assessments will be made to determine level of post-operative wound drainage following TJA.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01097135 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The secondary objectives will focus on wound assessment and signs and symptoms of infection from TJA until discharge.
Length of hospital stay
Need for readmission or reoperation for up to 6 weeks following TJA
Incidence of surgical skin infection at the first post-operative visit (6 weeks following surgery)
Incidence of skin blistering.
Scar cosmesis at the first post-operative visit.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluating the Effectiveness of 2 Surgical Skin Preparation Methods in Reducing Surgical Wound Drainage After Total Hip or Knee Replacement

Official Title ^ICMJE

Prospective, Randomized Clinical Study to Evaluate the Efficacy of 2 Surgical Skin Preparations in Reducing Wound Drainage Following Total Joint Arthroplasty

Brief Summary

Surgical skin complications can be costly and could contribute to extended in-patient stay following total joint replacement or even the need for re-admission. If efficacy in reducing the incidence of post-operative wound drainage and, in turn, surgical wound complications can be demonstrated, it may also reduce the length of hospital stay and the need for revision surgery or readmission. The aim of this research is to investigate the incidence of post-operative wound drainage following elective total joint arthroplasty using two surgical skin preparation protocols.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment

Condition ^ICMJE

Drainage

Intervention ^ICMJE

Drug: Duraprep Surgical Solution

Study Arm (s)

No Intervention: Standard surgical skin preparation
Active Comparator: Standard Surgical Skin Preparation with Duraprep
Intervention: Drug: Duraprep Surgical Solution

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

December 2011

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects who are able and willing to provide informed consent
Male and non-pregnant, non-lactating, postmenopausal or surgically sterilized female subjects between the ages of 18-80 years old.
Subjects deemed able to comply with study visit schedule and procedures.
Subjects undergoing elective total hip arthroplasty or elective total knee arthroplasty.

Exclusion Criteria:

Subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or bilateral total hip arthroplasty.
Subjects undergoing non-elective total joint procedures.
Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception.
Subjects with known allergies or previous skin reaction to iodine povacrylex

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Tiffany Morrison, MS

267-339-7818

tiffany.morrison@rothmaninstitute.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01097135

Other Study ID Numbers ^ICMJE

RIFJPAR-10-02

Has Data Monitoring Committee

Not Provided

Responsible Party

Javad Parvizi, MD, Rothman Institute

Study Sponsor ^ICMJE

Rothman Institute Orthopaedics

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Javad Parvizi, MD, FRCS

Rothman Institute

Information Provided By

Rothman Institute Orthopaedics

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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