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Does the Addition of Hydrogen Peroxide to Chlorhexidine Skin Prep to Treat P. Acnes in the Shoulder

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ClinicalTrials.gov Identifier: NCT03656588
Recruitment Status : Enrolling by invitation
First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Brief Summary:
This is a prospective, randomized controlled trial to evaluate the ability of hydrogen peroxide preparation in addition to chlorhexidine to decrease the colonization of Propionibacterium acnes(a bacteria commonly found in the dermis of the skin surrounding the shoulder in order to decrease postoperative joint infection.

Condition or disease Intervention/treatment Phase
Propionibacterium Infection Drug: a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol Drug: Iodine scrub and ChloraPrep alone Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does the Addition of Hydrogen Peroxide to Chlorhexidine Preoperative Skin Preparation Reduce the Rate of Propionibacterium Acnes Positive Culture in the Shoulder
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : February 2019


Arm Intervention/treatment
Active Comparator: a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by Drug: a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol
a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol

Active Comparator: b. Iodine scrub and ChloraPrep alone Drug: Iodine scrub and ChloraPrep alone
Iodine scrub and ChloraPrep alone




Primary Outcome Measures :
  1. colonization of p.acnes in the dermis of the shoulder [ Time Frame: 14 days in culture ]
    number of colony forming units grown in bacterial culture



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. All male patients (>18) undergoing shoulder arthroscopy

Exclusion Criteria:

  1. Female patients
  2. Patients with active acne
  3. Patients who have taken antibiotics within a month of their surgery
  4. Subjects allergic to any of the following agents:

    o Benzoyl peroxide

  5. Subjects with psoriatic/eczematous lesions on the shoulder girdle.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656588


Locations
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics

Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT03656588     History of Changes
Other Study ID Numbers: 2018SNam2
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Iodine
Cadexomer iodine
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs