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

Rothman Institute Orthopaedics600 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

600

Conditions

Drainage

Interventions

Duraprep Surgical Solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Up to one year following surgery

Secondary Outcomes

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