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

Study Overview
=================
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.

Official Title
-----------------
Prospective, Randomized Clinical Study to Evaluate the Efficacy of 2 Surgical Skin Preparations in Reducing Wound Drainage Following Total Joint Arthroplasty

Conditions
-----------------
Drainage

Intervention / Treatment
-----------------
* Drug: Duraprep Surgical Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are able and willing to provide informed consent Male and non-pregnant, non-lactating, postmenopausal or surgically sterilized female subjects between the ages of 18-80 years old. Subjects deemed able to comply with study visit schedule and procedures. Subjects undergoing elective total hip arthroplasty or elective total knee arthroplasty. Exclusion Criteria: Subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or bilateral total hip arthroplasty. Subjects undergoing non-elective total joint procedures. Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception. Subjects with known allergies or previous skin reaction to iodine povacrylex

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard surgical skin preparation<br> | |
| Active Comparator: Standard Surgical Skin Preparation with Duraprep<br>standard surgical skin prep | Drug: Duraprep Surgical Solution<br> <br> |

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 | Measure Description | 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 |