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

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Propionibacterium Infection

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT03656588

2018SNam2

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

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

Active Comparator group

Treatment:

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

Active Comparator group

Treatment:

Drug: Iodine scrub and ChloraPrep alone