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

Not Applicable

Completed

• Conditions: Drainage
• Interventions: Drug: Duraprep Surgical Solution

• Registration Number: NCT01097135
• Lead Sponsor: Rothman Institute Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-04-01
• Primary Completion: 2011-11
• Study Completion: 2012-12
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Surgical Skin Preparation with Duraprep	Duraprep Surgical Solution	standard surgical skin prep

Primary Outcome Measures

Name	Time	Method
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	Up to one year following surgery	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

Name	Time	Method
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

Trial Locations

Locations (1)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States