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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2019-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Propionibacterium Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by

Group Type ACTIVE_COMPARATOR

a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol

Intervention Type DRUG

a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol

b. Iodine scrub and ChloraPrep alone

Group Type ACTIVE_COMPARATOR

Iodine scrub and ChloraPrep alone

Intervention Type DRUG

Iodine scrub and ChloraPrep alone

Interventions

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a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol

Intervention Type DRUG

Iodine scrub and ChloraPrep alone

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No