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

This study has been completed.
Information provided by (Responsible Party):
Tiffany Morrison, MS, Rothman Institute Orthopaedics Identifier:
First received: March 30, 2010
Last updated: September 16, 2013
Last verified: September 2013
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 Intervention
Drainage Drug: Duraprep Surgical Solution

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Tiffany Morrison, MS, Rothman Institute Orthopaedics:

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

Estimated Enrollment: 600
Study Start Date: March 2010
Study Completion Date: December 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard surgical skin preparation
Active Comparator: Standard Surgical Skin Preparation with Duraprep
standard surgical skin prep
Drug: Duraprep Surgical Solution


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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01097135

United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
Principal Investigator: Javad Parvizi, MD, FRCS Rothman Institute
  More Information

Responsible Party: Tiffany Morrison, MS, Manager, Clinical Trials, Rothman Institute, Rothman Institute Orthopaedics Identifier: NCT01097135     History of Changes
Other Study ID Numbers: RIFJPAR-10-02
Study First Received: March 30, 2010
Last Updated: September 16, 2013 processed this record on September 21, 2017