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

Phase 3

• Conditions: C. Acnes; Postoperative Infection; Phototherapy; Arthroscopic Rotator Cuff Repair; Shoulder Surgery
• Interventions: Procedure: Skin Biopsy; Drug: 5 Aminolevulinic Acid + Phototherapy

• Registration Number: NCT04636242
• Lead Sponsor: Rothman Institute Orthopaedics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-22
• Study First Submitted: 2020-10-21
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-18
• Last Update Submitted: 2020-11-18
• Study First Posted: 2020-11-19
• Last Update Posted: 2020-11-19
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Control Group	Skin Biopsy	patient will undergo standard of care surgery
Group 1: Phototherapy Group	Skin Biopsy	patient will be instructed to apply 5-aminolevulinic acid HCL topical solution to their shoulder prior to their surgery. 16 minutes before skin incision a blue light will be applied to the area of the shoulder where the 5-ALA was administered
Group 1: Phototherapy Group	5 Aminolevulinic Acid + Phototherapy	patient will be instructed to apply 5-aminolevulinic acid HCL topical solution to their shoulder prior to their surgery. 16 minutes before skin incision a blue light will be applied to the area of the shoulder where the 5-ALA was administered

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Decrease Rate of Postoperative Infection	3 months	The change in the incidence of postoperative shoulder infections in participants treated with photodynamic therapy versus participants who were not

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States