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

NCT ID: NCT04636242

Last Updated: 2020-11-19

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

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-22

Study Completion Date

2021-08-31

Brief Summary

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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

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Conditions

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

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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Group 1: Phototherapy Group

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 Type EXPERIMENTAL

Skin Biopsy

Intervention Type PROCEDURE

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

5 Aminolevulinic Acid + Phototherapy

Intervention Type DRUG

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

Group 2: Control Group

patient will undergo standard of care surgery

Group Type ACTIVE_COMPARATOR

Skin Biopsy

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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SNAM19G.133

Identifier Type: -

Identifier Source: org_study_id