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

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ClinicalTrials.gov Identifier: NCT02919410
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

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

Condition or disease Intervention/treatment Phase
Surgical Wound Infection Device: iodophor-impregnated adhesive drapes Other: No adhesive drapes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Prevention
Study Start Date : October 2014
Actual Primary Completion Date : May 2016

Arm Intervention/treatment
Active Comparator: Surgery performed using iodophor-impregnated adhesive drapes Device: iodophor-impregnated adhesive drapes
Surgery performed without iodophor-impregnated adhesive drapes Other: No adhesive drapes



Primary Outcome Measures :
  1. bacterial count from skin swabs [ Time Frame: Immediately post-surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT02919410    
Other Study ID Numbers: JPAR2015
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Wound Infection
Surgical Wound Infection
Surgical Wound
Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes