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
About this trial
This is an interventional prevention trial for Surgical Wound Infection
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
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
NCT ID
NCT02919410
First Posted
September 27, 2016
Last Updated
September 28, 2016
Sponsor
Rothman Institute Orthopaedics
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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