Effects of Light Therapy on Skin Bacteria in the Groin to Improve Preoperative Skin Disinfection
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
University Hospital Zurich
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Achermann Yvonne
044 255 34 02
yvonne.achermann@clutterusz.chUniversity Hospital Zurich
(BASEC)
Informazioni generali
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)
Informazioni scientifiche
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)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
15.07.2019
(BASEC)
ID di studio ICTRP
NCT04067843 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
EFFECTS OF PHOTODYNAMIC THERAPY ON THE HUMAN INGUINAL SKIN MICROBIOME TO IMPROVE ANTISEPTIC EFFECT (BASEC)
Titolo accademico
Effects of Photodynamic Therapy on the Human Inguinal Skin Microbiome to Improve Antiseptic Effect - a Pilot Study (ICTRP)
Titolo pubblico
Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study (ICTRP)
Malattie studiate
Postoperative Wound Infection Deep Incisional Surgical Site;Prosthesis and Implants;Surgical Site Infection;Prosthetic Joint Infection (ICTRP)
Intervento studiato
Procedure: Photodynamic treatment (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
2. Microbiome analysis 3 weeks after photodynamic treatment;1. Microbiome analysis immediately after photodynamic treatment (ICTRP)
Phylogenetic comparisons of isolated bacteria (ICTRP)
Data di registrazione
09.08.2019 (ICTRP)
Inclusione del primo partecipante
08.08.2019 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
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)
ID secondari
2019-005252 (ICTRP)
Risultati-Dati individuali dei partecipanti
Undecided (ICTRP)
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/show/NCT04067843 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile