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

Status:

completed 07/2024

Aims:

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 [COT] and Sympatex^® [SYM]) as part of the "Tertiary Individual Prevention" measure (TIP) of occupational skin diseases on the hands.

Substudy 1: "Testing the user acceptance and effectiveness of SYM and COT 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 SYM or COT gloves overnight in a therapeutic setting.

Substudy 2: "Testing the user acceptance and effectiveness of SYM and COT 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 SYM or COT gloves overnight in private settings. In addition, it is to be investigated whether SYM or COT gloves are suitable as glove liners for reducing sweating under the usual liquid-tight gloves in the professional environment.

Activities/Methods:

Substudy 1: A total collective of 300 TIP patients will test gloves made of COT or SYM underneath a COT glove (SYM/COT) overnight in two subcollectives. 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 (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. At the end of the wearer trial, participants fill out a questionnaire on the night wear trial.

Substudy 2: The total collective of 300 patients already recruited for substudy 1 continues the nightly testing gloves made of SYM or COT 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 gloves made of SYM or COT are tested for one month on both hands under the usual protective gloves used in everyday working life (approx. 4 weeks). At the end of the user trial, the participants fill out a health questionnaire and a short questionnaire on the wearer trial. In addition, about three weeks after the in-patient stay 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.

Results:

Sub-study 1: The hand dermatoses improved in all groups. No substantial intergroup differences regarding severity (OHSI) and health-related quality of life (QOLHEQ) were observed. SYM/COT received better ratings regarding climate conditions and tactility while COT showed superiority in fit, wearing comfort and practicality.

Sub-study 2: The hand dermatoses worsened in both groups during the workplace trial. No substantial intergroup differences regarding disease severity and HRQoL were observed. Both GLs did not impair work performance and were applicable in various work activities. SYM received better ratings regarding climate conditions, mobility and tactility. COT showed superiority in fit, donning and doffing.

SYM and COT were well tolerated and accepted suggesting that SYM is a reasonable alternative for COT as comfort gloves and glove liners in patients with hand dermatoses. The choice of material of GLs may depend on individual requirements, needs and preferences (e.g., skin condition, occupation-specific requirements).

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