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NCT02919410 Clinical Trial

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

Surgical Wound Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02919410
Other study ID # JPAR2015
Secondary ID
Status Completed
Phase N/A
First received September 27, 2016
Last updated September 28, 2016
Start date October 2014

Study information
Verified date September 2016
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date May 2016
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• iodophor-impregnated adhesive drapes

Other:
• No adhesive drapes

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Outcome
Type Measure Description Time frame Safety issue
Primary bacterial count from skin swabs Immediately post-surgery
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