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.

Study Overview

• Status: Completed
• Conditions: Drainage
• Intervention / Treatment: Drug: Duraprep Surgical Solution

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to one year following surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics
• Collaborators: 3M
• Investigators: Principal Investigator: Javad Parvizi, MD, FRCS, Rothman Institute

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: March 30, 2010
• First Submitted That Met QC Criteria: March 30, 2010
• First Posted (ESTIMATE): April 1, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 17, 2013
• Last Update Submitted That Met QC Criteria: September 16, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: RIFJPAR-10-02