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

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ClinicalTrials.gov Identifier: NCT04636242
Recruitment Status : Enrolling by invitation
First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
C. Acnes Phototherapy Postoperative Infection Arthroscopic Rotator Cuff Repair Shoulder Surgery Procedure: Skin Biopsy Drug: 5 Aminolevulinic Acid + Phototherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis
Actual Study Start Date : August 22, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: 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
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

Active Comparator: Group 2: Control Group
patient will undergo standard of care surgery
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




Primary Outcome Measures :
  1. 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. [ Time Frame: 13 days ]

Secondary Outcome Measures :
  1. Decrease Rate of Postoperative Infection [ Time Frame: 3 months ]
    The change in the incidence of postoperative shoulder infections in participants treated with photodynamic therapy versus participants who were not



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women are being excluded because studies have shown that men have a higher bacterial burden of C. acnes than females. The male predisposition has been linked with the habitat of C. acnes being in the hair follicles and therefore the upper body of males would harbor more of the bacterium than females after shoulder surgery.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636242


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04636242    
Other Study ID Numbers: SNAM19G.133
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents