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

Propionibacterium Infection Clinical Trial

Official title:

Does the Addition of Hydrogen Peroxide to Chlorhexidine Preoperative Skin Preparation Reduce the Rate of Propionibacterium Acnes Positive Culture in the Shoulder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03656588
• Other study ID #: 2018SNam2
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: February 2019

Study information

• Verified date: August 2018
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: February 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Propionibacterium Infection

Intervention

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
• Iodine scrub and ChloraPrep alone
Iodine scrub and ChloraPrep alone

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	colonization of p.acnes in the dermis of the shoulder	number of colony forming units grown in bacterial culture	14 days in culture