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Completed

NCT Number: NCT01097135

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

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.

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Key information

Conditions

Drainage

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duraprep Surgical Solution

Drug

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

    Time frame: 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 outcomes

  1. The secondary objectives will focus on wound assessment and signs and symptoms of infection from TJA until discharge.

    Time frame: until hospital discharge

  2. Length of hospital stay

    Time frame: until hospital discharge

  3. Need for readmission or reoperation for up to 6 weeks following TJA

    Time frame: 6 weeks post-op

  4. Incidence of surgical skin infection at the first post-operative visit (6 weeks following surgery)

    Time frame: 6 weeks post-op

  5. Incidence of skin blistering.

    Time frame: up to one year post-op

  6. Scar cosmesis at the first post-operative visit.

    Time frame: up to 6 weeks post-op

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Collaborators

  • 3M

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Apr 1, 2010
Registry last updated
Sep 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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