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

September 28, 2016 updated by: Rothman Institute Orthopaedics
This is a prospective, randomized control trial evaluating the efficacy of iodophor-impregnated adhesive drapes for reducing bacterial count in hip surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bacterial count from skin swabs
Time Frame: Immediately post-surgery
Immediately post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 28, 2016

First Posted (Estimate)

September 29, 2016

Study Record Updates

Last Update Posted (Estimate)

September 29, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JPAR2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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