Effects of Light Therapy on Skin Bacteria in the Groin to Improve Preoperative Skin Disinfection
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
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)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
University Hospital Zurich
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Achermann Yvonne
044 255 34 02
yvonne.achermann@clutterusz.chUniversity Hospital Zurich
(BASEC)
Informations générales
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)
Informations scientifiques
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)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
15.07.2019
(BASEC)
Identifiant de l'essai ICTRP
NCT04067843 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
EFFECTS OF PHOTODYNAMIC THERAPY ON THE HUMAN INGUINAL SKIN MICROBIOME TO IMPROVE ANTISEPTIC EFFECT (BASEC)
Titre académique
Effects of Photodynamic Therapy on the Human Inguinal Skin Microbiome to Improve Antiseptic Effect - a Pilot Study (ICTRP)
Titre public
Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study (ICTRP)
Maladie en cours d'investigation
Postoperative Wound Infection Deep Incisional Surgical Site;Prosthesis and Implants;Surgical Site Infection;Prosthetic Joint Infection (ICTRP)
Intervention étudiée
Procedure: Photodynamic treatment (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
2. Microbiome analysis 3 weeks after photodynamic treatment;1. Microbiome analysis immediately after photodynamic treatment (ICTRP)
Phylogenetic comparisons of isolated bacteria (ICTRP)
Date d'enregistrement
09.08.2019 (ICTRP)
Inclusion du premier participant
08.08.2019 (ICTRP)
Sponsors secondaires
non disponible
Contacts supplémentaires
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 secondaires
2019-005252 (ICTRP)
Résultats-Données individuelles des participants
Undecided (ICTRP)
Informations complémentaires sur l'essai
https://clinicaltrials.gov/show/NCT04067843 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible