Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis

Shoulder Surgery Clinical Trial

Official title:

Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04636242
• Other study ID #: SNAM19G.133
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: August 22, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2020
• 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 evaluation the ability of 5-aminolevulinic acid HCL topical solution photodynamic therapy to decrease the colonization of Cutibacterium acnes (C. acnes- a bacteria commonly found in the dermis of the skin surrounding the shoulder) in order to decrease postoperative joint infections. -Aminolevulinic acid (ALA) is a naturally occurring metabolite in the synthesis of pathway of cellular heme production. Adding ALA to bacteria encourages porphyrin production which serve as the immediate precursors to heme production. When these porphyrins are illuminated with blue light at an emission peak of 407-420nm, these metabolites become exothermic and cause internal destruction of the bacterial cells. This therapy does not cause any damage to the mammalian cells, which makes PDT safe for human skin treatment.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All male patients (>18) undergoing shoulder arthroscopy)

Exclusion Criteria:

• Female patients
• Patients with active acnes
• Patients who have taken antibiotics within a month of their surgery
• Subjects with psoriatic/eczematous lesions on the shoulder girdle
• Patients on anticoagulant therapy
• Patients who have a known allergy to any of the agents used in the study protocol

Related Conditions & MeSH terms

• Acne Vulgaris
• Arthroscopic Rotator Cuff Repair
• C. Acnes
• Phototherapy
• Postoperative Infection
• Shoulder Surgery

Intervention

Procedure:
• Skin Biopsy
A Biopsy of the skin where the arthroscopic instrument will be placed, will be taken and sent to the microbiology lab for analysis

Drug:
• 5 Aminolevulinic Acid + Phototherapy
5 aminolevulinic acid solution will be placed on the skin of the shoulder and the participant will receive Photodynamic therapy on the morning of surgery

Locations

Country	Name	City	State
United States	Rothman Orthopaedic 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	Change in the number of patients who have microbiological results positive for the bacteria C. acnes after treatment with 5-aminolevulinic acid-photodynamic therapy (ALA-PDT) versus those who were not.		13 days
Secondary	Decrease Rate of Postoperative Infection	The change in the incidence of postoperative shoulder infections in participants treated with photodynamic therapy versus participants who were not	3 months