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

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Completed

CT.gov ID

NCT01097135

Collaborator

3M (Industry)

600

Enrollment

Location

Arms

33.1

Duration (Months)

18.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Drainage	Drug: Duraprep Surgical Solution	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Rothman Institute Orthopaedics
3M

Investigators

Principal Investigator: Javad Parvizi, MD, FRCS, Rothman Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tiffany Morrison, MS, Manager, Clinical Trials, Rothman Institute, Rothman Institute Orthopaedics

ClinicalTrials.gov Identifier:

NCT01097135

Other Study ID Numbers:

RIFJPAR-10-02

First Posted:

Apr 1, 2010

Last Update Posted:

Sep 17, 2013

Last Verified:

Sep 1, 2013

Study Results

No Results Posted as of Sep 17, 2013