Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Phototherapy Group | Experimental | 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 2: Control Group | Active Comparator | patient will undergo standard of care surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin Biopsy | Procedure | A Biopsy of the skin where the arthroscopic instrument will be placed, will be taken and sent to the microbiology lab for analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Orthopaedic Institute | Philadelphia | Pennsylvania | 19107 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 5 Aminolevulinic Acid + Phototherapy | 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 |
|
| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013812 | Therapeutics |
Not provided
Not provided