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

NCT01097135 | Completed

• 1 other identifier: RIFJPAR-10-02
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Drainage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Standard surgical skin preparation

NO INTERVENTION

Standard Surgical Skin Preparation with Duraprep

ACTIVE COMPARATOR

standard surgical skin prep

Drug: Duraprep Surgical Solution

Interventions

Duraprep Surgical Solution DRUG

Standard Surgical Skin Preparation with Duraprep

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead
• 3M: collaborator

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Study Officials

• Javad Parvizi, MD, FRCS

  Rothman Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager, Clinical Trials, Rothman Institute

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: April 1, 2010
• Study Start: March 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2012
• Last Updated: September 17, 2013

Record last verified: 2013-09

Locations

US (1)