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

March 30, 2010
September 16, 2013
March 2010
November 2011   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01097135 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Evaluating the Effectiveness of 2 Surgical Skin Preparation Methods in Reducing Surgical Wound Drainage After Total Hip or Knee Replacement
Prospective, Randomized Clinical Study to Evaluate the Efficacy of 2 Surgical Skin Preparations in Reducing Wound Drainage Following Total Joint Arthroplasty

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Drainage
Drug: Duraprep Surgical Solution
  • No Intervention: Standard surgical skin preparation
  • Active Comparator: Standard Surgical Skin Preparation with Duraprep
    standard surgical skin prep
    Intervention: Drug: Duraprep Surgical Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
December 2012
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01097135
RIFJPAR-10-02
Not Provided
Tiffany Morrison, MS, Rothman Institute Orthopaedics
Rothman Institute Orthopaedics
3M
Principal Investigator: Javad Parvizi, MD, FRCS Rothman Institute
Rothman Institute Orthopaedics
September 2013

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