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

Rothman Institute Orthopaedics logo

Rothman Institute Orthopaedics

Status

Completed

Conditions

Drainage

Treatments

Drug: Duraprep Surgical Solution

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01097135
RIFJPAR-10-02

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

600 participants in 2 patient groups

Standard surgical skin preparation
No Intervention group
Standard Surgical Skin Preparation with Duraprep
Active Comparator group
Description:
standard surgical skin prep
Treatment:
Drug: Duraprep Surgical Solution

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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