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 : Unknown
Verified August 2018 by Rothman Institute Orthopaedics.
Recruitment status was: Enrolling by invitation
First Posted : September 4, 2018
Last Update Posted : September 4, 2018
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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 |
- 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 |
Inclusion Criteria:
1. All male patients (>18) undergoing shoulder arthroscopy
Exclusion Criteria:
- Female patients
- Patients with active acne
- Patients who have taken antibiotics within a month of their surgery
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Subjects allergic to any of the following agents:
o Benzoyl peroxide
- Subjects with psoriatic/eczematous lesions on the shoulder girdle.

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
United States, Pennsylvania | |
Rothman Institute | |
Philadelphia, Pennsylvania, United States, 19107 |
Responsible Party: | Rothman Institute Orthopaedics |
ClinicalTrials.gov Identifier: | NCT03656588 |
Other Study ID Numbers: |
2018SNam2 |
First Posted: | September 4, 2018 Key Record Dates |
Last Update Posted: | September 4, 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 |
Iodine Chlorhexidine Chlorhexidine gluconate Cadexomer iodine Hydrogen Peroxide Anti-Infective Agents, Local |
Anti-Infective Agents Disinfectants Dermatologic Agents Trace Elements Micronutrients Physiological Effects of Drugs |