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.
Sponsor:
Collaborator:
3M
Information provided by (Responsible Party):
Tiffany Morrison, MS, Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT01097135
First received: March 30, 2010
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: until hospital discharge ] [ Designated as safety issue: No ]
  • Need for readmission or reoperation for up to 6 weeks following TJA [ Time Frame: 6 weeks post-op ] [ Designated as safety issue: No ]
  • Incidence of surgical skin infection at the first post-operative visit (6 weeks following surgery) [ Time Frame: 6 weeks post-op ] [ Designated as safety issue: No ]
  • Incidence of skin blistering. [ Time Frame: up to one year post-op ] [ Designated as safety issue: No ]
  • Scar cosmesis at the first post-operative visit. [ Time Frame: up to 6 weeks post-op ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: March 30, 2010
Last Updated: September 16, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014