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

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ClinicalTrials.gov Identifier: NCT01097135
Recruitment Status : Completed
First Posted : April 1, 2010
Last Update Posted : September 17, 2013
Sponsor:
Collaborator:
3M
Information provided by (Responsible Party):
Tiffany Morrison, MS, Rothman Institute Orthopaedics

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.

Condition or disease Intervention/treatment Phase
Drainage Drug: Duraprep Surgical Solution Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Clinical Study to Evaluate the Efficacy of 2 Surgical Skin Preparations in Reducing Wound Drainage Following Total Joint Arthroplasty
Study Start Date : March 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Standard surgical skin preparation
Active Comparator: Standard Surgical Skin Preparation with Duraprep
standard surgical skin prep
Drug: Duraprep Surgical Solution



Primary Outcome Measures :
  1. 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 [ Time Frame: Up to one year following surgery ]
    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.


Secondary Outcome Measures :
  1. The secondary objectives will focus on wound assessment and signs and symptoms of infection from TJA until discharge. [ Time Frame: until hospital discharge ]
  2. Length of hospital stay [ Time Frame: until hospital discharge ]
  3. Need for readmission or reoperation for up to 6 weeks following TJA [ Time Frame: 6 weeks post-op ]
  4. Incidence of surgical skin infection at the first post-operative visit (6 weeks following surgery) [ Time Frame: 6 weeks post-op ]
  5. Incidence of skin blistering. [ Time Frame: up to one year post-op ]
  6. Scar cosmesis at the first post-operative visit. [ Time Frame: up to 6 weeks post-op ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097135


Locations
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
3M
Investigators
Principal Investigator: Javad Parvizi, MD, FRCS Rothman Institute

Responsible Party: Tiffany Morrison, MS, Manager, Clinical Trials, Rothman Institute, Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT01097135     History of Changes
Other Study ID Numbers: RIFJPAR-10-02
First Posted: April 1, 2010    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: September 2013