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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Effect of Photodynamic Therapy on Skin Microbiome. Single Center Study (PHOMIC-II)

NCTNCT04618276 (opens ClinicalTrials.gov in a new tab)Other id2020_PHOMIC-II
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
20 participants (actual)
Sponsor
University of Zurich · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Switzerland

Start
15 Jan 2021
Primary completion
24 Jun 2021
Completion
24 Jun 2021
First posted
5 Nov 2020
Last update posted
15 Oct 2024
Conditions
Postoperative Wound Infection Deep Incisional Surgical Site · Prosthesis and Implants · Surgical Site Infection · Prosthetic Joint Infection

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20212022
  1. N/A

    Effect of Photodynamic Therapy on Skin Microbiome. Single Center Study (PHOMIC-II)

    NCT04618276

    15 Jan 2021 to 24 Jun 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The overarching aim of this research project is to prevent orthopedic implant-associated infections. This study aims to investigate if PDT has an effect on bacterial skin colonization in order to improve skin antisepsis strategies for the prevention of surgical site infections.

Interventions

  • Photodynamic TherapyOther

Arms3

  • Experimental

    Arm A (5-ALA group)

    1. Skin swab for culture in the groin for baseline 2. PDT with 5% topical 5-ALA as the prodrug for the photosensitizer Pp IX 3. Skin swab for culture 4. Skin antisepsis 5. Skin swab for culture

  • Experimental

    Arm B (Methylene Blue group)

    1. Skin swab for culture in the groin for baseline 2. PDT with 0.01% methylene blue based photosensitizer (NF-031) 3. Skin swab for culture 4. Skin antisepsis 5. Skin swab for culture

  • No intervention

    Control group

    1. Skin swab for culture in the groin for baseline 2. NO PDT 3. Skin antisepsis 4. Skin swab for culture

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Number of Patients With no Growth of Bacteria on the Skin

    Time frame · Day 0 after PDT

    Registry description

    Quantitative evaluation of bacterial density and species from skin swabs taken before PDT, immeadiately after PDT, and after after skin antisepsis using culture technique

  2. Number of Patients With no Growth of Bacteria on the Skin on After 1 Day

    Time frame · Day 1 after PDT

    Registry description

    Quantitative evaluatuation of bacterial density and species from skin swabs taken 1 day after PDT before and after skin antisepsis

  3. Number of Patients With no Growth of Bacteria on the Skin After 3 Days

    Time frame · Day 3 after PDT

    Registry description

    Quantitative evaluatuation of bacterial density and species from skin swabs taken 3 days after PDT before and after skin antisepsis

  4. Number of Patients With no Growth of Bacteria on the Skin on Day 5 Number of Patients With no Growth of Bacteria on the Skin on Day 5

    Time frame · Day 5

    Registry description

    Quantitative evaluatuation of bacterial density and species from skin ...

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Day 0 after PDT

Number of Patients With no Growth of Bacteria on the Skin

GroupValue (Participants)
Arm A (MAL Group)3
Arm B (Methylene Blue Group)7
Primary outcomeCount of participants· Day 1 after PDT

Number of Patients With no Growth of Bacteria on the Skin on After 1 Day

GroupValue (Participants)
Arm A (5-ALA Group)2
Arm B (Methylene Blue Group)7
Primary outcomeCount of participants· Day 3 after PDT

Number of Patients With no Growth of Bacteria on the Skin After 3 Days

GroupValue (Participants)
Arm A (5-ALA Group)3
Arm B (Methylene Blue Group)6
Primary outcome· Day 5

Number of Patients With no Growth of Bacteria on the Skin on Day 5 Number of Patients With no Growth of Bacteria on the Skin on Day 5

GroupValue
Arm A (5-ALA Group)not posted
Arm B (Methylene Blue Group)not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Arm A (MAL Group)1. Skin swab for culture in the groin for baseline 2. PDT with 5% topical methyl aminolevulinate (MAL) as the prodrug for the photosensitizer Pp IX 3. Skin swab for culture 4. Skin antisepsis 5. Skin swab for culture Photodynamic Therapy: PDT with two different photosensitizers0 / 100 / 100 / 10
Arm B (Methylene Blue Group)1. Skin swab for culture in the groin for baseline 2. PDT with 0.01% methylene blue based photosensitizer (NF-031) 3. Skin swab for culture 4. Skin antisepsis 5. Skin swab for culture Photodynamic Therapy: PDT with two different photosensitizers0 / 100 / 100 / 10
Control Group1. Skin swab for culture in the groin for baseline 2. NO PDT 3. Skin antisepsis 4. Skin swab for culture0 / 200 / 200 / 20

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 100 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy male and female participants ≥ 18 years who * volunteer for the pilot study in which a routine photodynamic treatment in the Department of Dermatology will be applied and effect of skin colonization will be analyzed, and * an informed consent is signed by the participant (after information about the project). Exclusion Criteria: * Pregnant and lacting women * Participants with inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc., * Participants taking antibiotics in the 14 days prior to PDT or until follow-up at 21 days * Participants who received oral retinoid therapy within the last 6 months * Participants who received anti-inflammatory agents as NSAR within the 14 days prior and after the PDT * Participants taking any photosensitizing drugs within 4 weeks prior to PDT * Participants who had a history of photosensitivity disorder * Fitzpatrick's skin phototype V-VI

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