Occupational skin diseases, hand eczema
Conditions
Interventions
Group 1: Intervention group 1: Testing of Sympatex®-gloves (both hands), [Substudy 1: Testing as glove liners in combination with cotton gloves
Substudy 2 - Night wear test: Testing as glove liners in combination with cotton gloves
Substudy 2 - User test: Testing as glove liners in combination with activity-specific occlusive protective gloves].
Group 2: Intervention group 2: Testing of cotton gloves (both hands) [Substudy 1: Si
substudy 2 - night wear test: testing as single cotton gloves
substudy 2 - user test: testing as glove liners in combination with occlusive activity-specific protective gloves].
Group 3: Control group: No testing of gloves overnight during the inpatient phase.
Sponsors
Institut für interdisziplinäre Dermatologische Prävention und Rehabilitation (iDerm) an der Universität Osnabrück
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Intervention groups: 1) Minimum age 18 years. 2) Insured by the Statutory social accident insurance BGW, regardless of the type of skin symptoms or diagnosis. 3) Occupational activity involving wearing of occlusive protective gloves. 4) No local therapy with therapeutically active ingredients overnight. (All emollients as well as urea up to 10% are allowed. Shale oil, salicylic acid etc. represent an exclusion criterion). 5) No clinical suspicion of mycosis. 6) No existence of acute injuries. 7) The patient is willing and able (e.g. good German language and writing skills) to actively participate in the study. 8) Signature of the declaration of consent / study participant information. Control group: 1) Minimum age 18 years. 2) Not insured by the BGW, regardless of the type of skin symptoms or diagnosis. 3) Occupational activity in the following sectors: Nursing / clinics human medicine / doctor's practices / dentistry; occupational rehabilitation / workshops; education / schools / training institutions; therapeutic practices (e.g. physiotherapists, occupational therapists); food sales (e.g. bakery, fresh food counter); food processing. 4) No gloves are or should be used overnight for therapeutic purposes. 5) The patient is willing and able (e.g. good German language and writing skills) to actively participate in the study. 6) No clinical suspicion of mycosis. 7) No existence of acute injuries. 8) No local therapy with therapeutically active ingredients overnight. (All emollients and urea up to 10% are allowed. Shale oil, salicylic acid etc. represent an exclusion criterion). 9) Signature of the declaration of consent / study participant information.
Exclusion criteria
Exclusion criteria: Intervention groups: 1) MRSA-positive swab (regardless of body part) 2) Overnight application of strongly occlusive externals and further preparations with urea >10% or salicylic acid. 3) Presence of acute injuries. 4) Evidence of a pre-existing mycosis. 5) Deterioration of the skin condition during the test which can be attributed to the wearing of gloves at night. Control group: 1) MRSA-positive swabs (regardless of body part) 2) Overnight gloves should be used for therapeutic purposes. 3) Presence of acute injuries. 4) Evidence of a pre-existing mycosis. 5) Overnight application of strongly occlusive topicals and preparations with urea >10% or salicylic acid; topicals applied during the day are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intervention groups: 1) "Osnabrueck Hand Eczema Severity Index" (OHSI): Assessment by physician according to the protocol at four consecutive points in time (T1 - T4) during the period of substudy 1 and at the beginning (T5) and end (T6) of substudy 2. 2) "Quality of Life in Hand Eczema Questionnaire" (QOLHEQ / health questionnaire for hand eczema patients): Written survey on the disease-specific quality of life before and after participation in the rehabilitation measure as well as after intervention study. 3) "photographic guide for the self-assessment of hand eczema": Written self-assement of the severity of hand eczema by patient prior to participation in the rehabilitation measure and during and after participation in the intervention study. 4) Written questioning on the night wearing of gloves in the inpatient setting. Time: end of the substudy 1. 5) Written questioning about the attempt to wear gloves at night in the home setting. Time: During the substudy 2. 6) Written questioning on the user trial of the gloves in the professional setting. Time: End of the substudy 2. Control group: 1) "Osnabrueck Hand Eczema Severity Index" (OHSI): Assessment by physician according to the protocol at four consecutive points in time (T1 - T4) during the period of rehabilitation measure. 2) "Quality of Life in Hand Eczema Questionnaire" (QOLHEQ / health questionnaire for hand eczema patients): Written survey on the disease-specific quality of life before and after participation in the rehabilitation measure. 3) "photographic guide for the self-assessment of hand eczema": Written self-assement of the severity of hand eczema by patient prior to participation in the rehabilitation measure. | — |
Secondary
| Measure | Time frame |
|---|---|
| (none) | — |
Countries
Germany
Contacts
Public ContactTheres Heichel
Institut für interdisziplinäre Dermatologische Prävention und Rehabilitation (iDerm) an der Universität Osnabrück; Universität Osnabrück - Institut für Gesundheitsforschung und Bildung (IGB) Abteilung Dermatologie, Umweltmedizin und Gesundheitstheorie
Outcome results
None listed