German Clinical Trials Register

„ProTection II - Multicenter study: "Tertiary individual prevention of occupational skin diseases through the use of semipermeable gloves made of Sympatex®"

Organizational Data

DRKS-ID:: DRKS00018860
Recruitment Status:: Recruiting complete, study complete
Date of registration in DRKS:: 2020-03-04
Last update in DRKS:: 2024-09-20
Registration type:: Retrospective

Acronym/abbreviation of the study

ProTection II

URL of the study

Brief summary in lay language

Main purpose: examination of the practicability and effectiveness of the standardised use (user acceptance; possibilities of use, reuse and reprocessing) of textile and semipermeable glove liners (cotton and Sympatex®) as part of the "Tertiary Individual Prevention" measure (TIP) of occupational skin diseases on the hands. Background: In many professions, protective gloves are worn to protect against skin-damaging substances. These consist mainly of occlusive (= impermeable) materials and thus lead to heat and moisture accumulation on the skin. In order to reduce these effects, up to now cotton glove liners are recommended; however, the disadvantage of these gloves is that during prolonged wearing the material becomes saturated due to the sweat absorbed. Semipermeable gloves made of Sympatex® can reduce or prevent these negative effects; however, they are currently only available as prototypes and are not yet available on the (free) market. Study participants: The study cohort is made up of 300 patients who are taking part in a three-weeks intervention measure for occupational skin dieaseses at various skin clinics as part of the "Tertiary Individual Prevention" measure (TIP). During the inpatient stay, treatment, training and counselling of the insured persons with severe occupational skin diseases (mainly hand eczema), which had been resistant to out-patient therapy, is provided. In two of the skin clinics, in addition to the two 300 patients (intervention groups), a control group of about 100 patients will be recruited, who will wear no cotton or Sympatex® gloves overnight during the inpatient stay. Substudy 1: "Testing the user acceptance and effectiveness of Sympatex® and cotton glove liners in the therapeutic setting (night wear test)". The aim of the 1st part of the study is to investigate the healing process of hand eczema under the influence of wearing Sympatex® or cotton gloves overnight in a therapeutic setting. Research questions/hypotheses: a) Does the Sympatex® glove liner material used in the context of the rehabilitative TIP measure show equally good skin compatibility compared to gloves made of cotton material? Do both materials equally not lead to a deterioration of the skin condition or delay healing? (OHSI Score: evidence of non-inferiority); b) Does Sympatex®-material show better user acceptance (e.g. wearing comfort) in the context of the TIP measure compared to the gloves made of cotton material? (Written survey on user acceptance: evidence of superiority); c) Does the nightly testing of different glove materials in the context of the rehabilitative TIP measure not lead to a deterioration in the perception or assessment of the disease-specific health-related quality of life? (QOLHEQ: evidence of inferiority). Methodology of Substudy 1: A total collective of 300 TIP patients will test Sympatex®-gloves (plus cotton gloves worn over them for shaping) or cotton gloves overnight in two subcollectives (150 people each). The glove-wearing trial is carried out in addition to the therapeutic measures over the entire duration of the patients' stay in the skin clinic (approx. 19 nights). In the course of the inpatient stay, the skin condition of the hands is assessed several times by a doctor using a score. At the beginning of the wearer trial, the study participants fill out a health questionnaire and a short questionnaire on the "severity of their own hand eczema". At the end of the wearer trial, study participants fill out a questionnaire on the night wear trial. Substudy 2: "Testing the user acceptance and effectiveness of Sympatex® and cotton glove liners in professional and private settings (user trial)". The aim of the 2nd part of the study is to investigate the healing process of hand eczema under the influence of wearing Sympatex® or cotton gloves overnight in private settings. In addition, it is to be investigated whether Sympatex® or cotton gloves are suitable as glove liners for reducing sweating under the usual liquid-tight gloves in the professional environment. Research questions/hypotheses: a) Does the Sympatex® glove liner material used in rehabilitative TIP measures show equally good skin compatibility compared to gloves made of cotton material? Do both materials equally not lead to a deterioration of the skin condition or delay healing? (OHSI Score: evidence of non-inferiority); b) Does Sympatex® glove liner material show better user acceptance in the context of post-stationary occupational rehabilitation compared to glove liner made of cotton material? (Written survey on user acceptance: evidence of superiority); c) Does the nightly testing of various glove materials in the context of the rehabilitative TIP measure not lead to a deterioration in the perception or assessment of the disease-specific health-related quality of life? (QOLHEQ: evidence of inferiority) Methodology of Substudy 2: The total collective of 300 patients already recruited for Subproject 1 continues the nightly testing of Sympatex® or cotton gloves for the 3-week phase following the inpatient stay. At the end of the wear trial, the study participants will fill out a questionnaire for the night wear trial. Subsequently, the Sympatex® or cotton glove liners are tested for one month (approx. 22 working days) on both hands under the usual protective gloves used in everyday working life. At the end of the user trial, the study participants fill out a health questionnaire and a short questionnaire on the wearer trial. In addition, about three weeks after the in-patient stay (2-3 days before resuming professional activity) and about four weeks after resuming professional activity, a follow-up visit to the in-patient rehabilitation centre takes place. At these appointments, the skin condition of the hands is assessed again by a doctor using a score.

Brief summary in scientific language

Background: Barrier-regenerative and occlusion-reducing effects of semipermeable gloves made of Sympatex® have been demonstrated several times in various studies. Sympatex® (Sympatex Technologies GmbH) is a synthetic membrane consisting of hydrophilic polyester and hydrophobic polyether molecules. The compact, poreless interlinking structure can promote the removal of moisture along the diffusion gradient at the molecular level, thereby inducing dynamic climate regulation between the skin surface, membrane and the space between the gloves. The use of the breathable membrane is therefore suitable as (comfort) underwear material under occlusive protective gloves in everyday working life as well as for the support of individual therapeutic measures for existing (occupational) skin diseases. Aim of the study and methodology: The iDerm (Institute for Interdisciplinary Dermatological Prevention and Rehabilitation) at the University of Osnabrück is conducting the above-mentioned multi-center study in cooperation with all TIP centers nationwide (Hamburg, Heidelberg, Bad Reichenhall) as well as with the Statutory Social Accident Insurance for Health Services and Welfare (BGW) from July 2019 to July 2021. The aim is to investigate the practicability and effectiveness of the standardised use of the semipermeable Sympatex® gloves in the Tertiary Individual Prevention measure (TIP), based on the previous study. For this purpose, a collective of 300 patients (all persons covered by BGW) of the TIP measure will test Sympatex® or cotton gloves in two subcollectives within the framework of a 19-day night wear test (subproject 1). This is followed by a further nighttime trial over the 3-week period of sick leave, as well as a 1-month trial in everyday working practice (sub-project 2). Both substudies are accompanied by multiple medical examinations with the visual "Osnabrück Hand Eczema Severity Index" (OHSI Score) as well as multiple written surveys of study participants on user acceptance and disease-specific quality of life ("Quality of Life in Hand Eczema Questionnaire (QOLHEQ)"). The results of the preliminary study ProTection I have shown that the semipermeable material is widely accepted by the majority of users in nighttime and professional contexts. In addition, it could be shown that the skin's regeneration process tends to be accelerated by covering it with the semipermeable membrane (after standardised irritation). The present study is an important step towards establishing Sympatex® gloves as an extension and optimisation of current secondary and tertiary preventive measures.

Health condition or problem studied

Free text:: Occupational skin diseases, hand eczema
Healthy volunteers:: No Entry

Interventions, Observational Groups

Arm 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].
Arm 2:: Intervention group 2: Testing of cotton gloves (both hands) [Substudy 1: Singular testing of cotton gloves; 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].
Arm 3:: Control group: No testing of gloves overnight during the inpatient phase.

Endpoints

Primary outcome:: 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 outcome:: (none)

Study Design

Purpose:

Prevention

Allocation:

Non-randomized controlled study

Control:

Control group receives no treatment

Phase:

N/A

Study type:: Interventional
Mechanism of allocation concealment:: No Entry
Blinding:: No

Assignment:: Other
Sequence generation:: No Entry
Who is blinded:: No Entry

Recruitment

Recruitment Status:: Recruiting complete, study complete

Reason if recruiting stopped or withdrawn:: No Entry

Recruitment Locations

Recruitment countries:

Germany

Number of study centers:

Multicenter study

Recruitment location(s):

University medical center Universitätsklinikum Heidelberg / Abteilung Berufsdermatologie Heidelberg
Medical center Institut für interdisziplinäre Dermatologische Prävention und Rehabilitation (iDerm) an der Universität Osnabrück Osnabrück
Medical center Institut für interdisziplinäre Dermatologische Prävention und Rehabilitation (iDerm), Standort Hamburg Hamburg
Medical center BG Klinik für Berufskrankheiten Bad Reichenhall Bad Reichenhall

Recruitment period and number of participants

Planned study start date:: No Entry

Actual study start date:: 2020-01-14

Planned study completion date:: No Entry

Actual Study Completion Date:: 2022-07-31

Target Sample Size:: 400

Final Sample Size:: 373

Inclusion Criteria

Sex:: All

Minimum Age:: 18 Years

Maximum Age:: no maximum age

Additional 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

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.

Addresses

Primary Sponsor

Address:: Institut für interdisziplinäre Dermatologische Prävention und Rehabilitation (iDerm) an der Universität Osnabrück
Prof. Dr. med. Swen Malte John
Am Finkenhügel 7a
49076 Osnabrück
Germany
Telephone:: No Entry
Fax:: No Entry
Contact per E-Mail:: Contact per E-Mail
URL:: http://www.iderm.de
Investigator Sponsored/Initiated Trial (IST/IIT):: Yes

Contact for Scientific Queries

Address:: 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
Prof. Dr. med. Swen Malte John
Am Finkenhügel 7a
49076 Osnabrück
Germany
Telephone:: 0541 969 2357
Fax:: 0541 969 2445
Contact per E-Mail:: Contact per E-Mail
URL:: http://www.iderm.de; www.igb.uni-osnabrueck.de/abteilungen/dermatologie_umweltmedizin_gesundheitstheorie.html

Contact for Public Queries

Address:: 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
M.Ed. Theres Heichel
Am Finkenhügel 7a
49076 Osnabrück
Germany
Telephone:: 0541 969 7409
Fax:: 0541 969 2445
Contact per E-Mail:: Contact per E-Mail
URL:: http://www.iderm.de; https://www.igb.uni-osnabrueck.de/abteilungen/dermatologie_umweltmedizin_gesundheitstheorie.html

Principal Investigator

Address:: 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
Prof. Dr. med. Swen Malte John
Am Finkenhügel 7a
49076 Osnabrück
Germany
Telephone:: 0541 969 2357
Fax:: 0541 969 2445
Contact per E-Mail:: Contact per E-Mail
URL:: http://www.iderm.de; www.igb.uni-osnabrueck.de/abteilungen/dermatologie_umweltmedizin_gesundheitstheorie.html

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:: Berufsgenossenschaft für Gesundheitsdienst und Wohlfahrtspflege (BGW)
Pappelallee 33/ 35/ 37
22089 Hamburg
Germany
Telephone:: No Entry
Fax:: No Entry
Contact per E-Mail:: Contact per E-Mail
URL:: http://www.bgw-online.de

Ethics Committee

Address Ethics Committee

Address:: Ethikkommission bei der Ärztekammer Niedersachsen, Unterkommission zur Beurteilung medizinischer Forschung am Menschen
Berliner Allee 20
30175 Hannover
Germany
Telephone:: +49-511-38023102
Fax:: No Entry
Contact per E-Mail:: Contact per E-Mail
URL:: http://www.aekn.de/aekn/kommissionen/ethikkommission

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:: 2019-05-20
Ethics committee number:: Ethik-36/2019
Vote of the Ethics Committee:: Approved
Date of the vote:: 2019-07-09

Further identification numbers

Other WHO Primary Registry or Data Provider ID:: No Entry
EudraCT Number:: No Entry

UTN (Universal Trial Number):

No Entry

EUDAMED Number: