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Bacterial Colonization With and Without Iodophor-impregnated Adhesive Drapes in Hip Surgery: a Prospective, Randomized Trial

Primary Purpose

Surgical Wound Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
iodophor-impregnated adhesive drapes
No adhesive drapes
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Wound Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Primary femoroacetabular osteoplasty (FAO) patients
  • Primary Periacetabular Osteotomy (PAO) patients

Exclusion Criteria:

  • Total hip arthroplasty (THA) patients
  • Revision FAO surgery
  • Septic or septic arthritis patients
  • Patients with systemic or topical allergy to iodine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    Surgery performed using iodophor-impregnated adhesive drapes

    Surgery performed without iodophor-impregnated adhesive drapes

    Arm Description

    Outcomes

    Primary Outcome Measures

    bacterial count from skin swabs

    Secondary Outcome Measures

    Full Information

    First Posted
    September 27, 2016
    Last Updated
    September 28, 2016
    Sponsor
    Rothman Institute Orthopaedics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02919410
    Brief Title
    Bacterial Colonization With and Without Iodophor-impregnated Adhesive Drapes in Hip Surgery: a Prospective, Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rothman Institute Orthopaedics

    4. Oversight

    5. Study Description

    Brief Summary
    This is a prospective, randomized control trial evaluating the efficacy of iodophor-impregnated adhesive drapes for reducing bacterial count in hip surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Wound Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable

    8. Arms, Groups, and Interventions

    Arm Title
    Surgery performed using iodophor-impregnated adhesive drapes
    Arm Type
    Active Comparator
    Arm Title
    Surgery performed without iodophor-impregnated adhesive drapes
    Arm Type
    Other
    Intervention Type
    Device
    Intervention Name(s)
    iodophor-impregnated adhesive drapes
    Intervention Type
    Other
    Intervention Name(s)
    No adhesive drapes
    Primary Outcome Measure Information:
    Title
    bacterial count from skin swabs
    Time Frame
    Immediately post-surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Primary femoroacetabular osteoplasty (FAO) patients Primary Periacetabular Osteotomy (PAO) patients Exclusion Criteria: Total hip arthroplasty (THA) patients Revision FAO surgery Septic or septic arthritis patients Patients with systemic or topical allergy to iodine

    12. IPD Sharing Statement

    Learn more about this trial

    Bacterial Colonization With and Without Iodophor-impregnated Adhesive Drapes in Hip Surgery: a Prospective, Randomized Trial

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