Effects of Light Therapy on Skin Bacteria in the Groin to Improve Preoperative Skin Disinfection
Zusammenfassung der Studie
Study Objective: It is known and natural that bacteria colonize the entire skin - including sweat and sebaceous glands. Before surgeries, the skin is disinfected to kill these bacteria. Unfortunately, this preventive measure is not 100% effective. There is a risk that remaining bacteria may be carried deep into the body by the surgical incision and may cause an infection. For this reason, current disinfection processes need to be questioned and improved. With this study at the University Hospital Zurich, we investigate whether light therapy can kill skin bacteria and reduce the size of sebaceous and sweat glands in the skin. This therapy is established at the Dermatology Clinic, is well tolerated, and does not cause any side effects.
(BASEC)
Untersuchte Intervention
Procedure: Participation in the study involves 4 appointments over 5 weeks. These take place either at the Clinic for Infectious Diseases or the Clinic for Dermatology. The first appointment lasts about 20 minutes and serves to inform about the study and to clarify participation. The second appointment lasts 4 hours and includes light therapy with skin swabs before and after. The third and fourth visits last between 15 and 30 minutes for monitoring skin bacteria and study completion.
(BASEC)
Untersuchte Krankheit(en)
We want to investigate with this project whether light therapy (medically photodynamic therapy) can reduce bacteria on the skin in the groin. This would lead to the usual preoperative skin disinfection before surgery lowering the risk of postoperative infection. Light therapy is an established therapy.
(BASEC)
All individuals who have reached the age of 18 can participate in this research project. (BASEC)
Ausschlusskriterien
Excluded are individuals who are undergoing treatment with the following medications: antibiotics, non-steroidal anti-inflammatory drugs 14 days before and during the study, photosensitizing drugs, or retinoids within the past 6 months. (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
University Hospital Zurich
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Achermann Yvonne
044 255 34 02
yvonne.achermann@clutterusz.chUniversity Hospital Zurich
(BASEC)
Allgemeine Auskünfte
University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology,
0041 44 255 34 02;0041 44 255 34 02
yvonne.achermann@clutterusz.ch(ICTRP)
Wissenschaftliche Auskünfte
University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology,
0041 44 255 34 02;0041 44 255 34 02
yvonne.achermann@clutterusz.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
15.07.2019
(BASEC)
ICTRP Studien-ID
NCT04067843 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
EFFECTS OF PHOTODYNAMIC THERAPY ON THE HUMAN INGUINAL SKIN MICROBIOME TO IMPROVE ANTISEPTIC EFFECT (BASEC)
Wissenschaftlicher Titel
Effects of Photodynamic Therapy on the Human Inguinal Skin Microbiome to Improve Antiseptic Effect - a Pilot Study (ICTRP)
Öffentlicher Titel
Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study (ICTRP)
Untersuchte Krankheit(en)
Postoperative Wound Infection Deep Incisional Surgical Site;Prosthesis and Implants;Surgical Site Infection;Prosthetic Joint Infection (ICTRP)
Untersuchte Intervention
Procedure: Photodynamic treatment (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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 the photodynamic treatment 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 the
photodynamic treatment (PDT)
- Participants who had a history of photosensitivity disorder
- Fitzpatrick's skin phototype V-VI
(ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
2. Microbiome analysis 3 weeks after photodynamic treatment;1. Microbiome analysis immediately after photodynamic treatment (ICTRP)
Phylogenetic comparisons of isolated bacteria (ICTRP)
Registrierungsdatum
09.08.2019 (ICTRP)
Einschluss des ersten Teilnehmers
08.08.2019 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Yvonne Achermann, MD;Yvonne Achermann, MD;Yvonne Achermann, yvonne.achermann@usz.ch, 0041 44 255 34 02;0041 44 255 34 02, University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology, (ICTRP)
Sekundäre IDs
2019-005252 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
Undecided (ICTRP)
Weitere Informationen zur Studie
https://clinicaltrials.gov/show/NCT04067843 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar