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CE marking for the Q-whet micro current wound stimulator

CE marking for the Q-whet micro current wound stimulator - CE marking for the Q-whet micro current wound stimulator

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45773
Enrollment
30
Registered
2018-06-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic wounds

Interventions

None listed

Sponsors

Jeroen Bosch Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with chronic wounds (at least 6 weeks old): - age older than 18 years - venous ulcers - arterial leg ulcers - ulcers of the lower limbs with mixed ethiology - pressure ulcers (grade 2 to 4) - diabetic foot ulcers - other difficult to treat wounds

Exclusion criteria

Exclusion criteria: Pregnancy an lactation Use of other internal electronic device (e.g. pacemaker, internale deflibrillator) Oncologic wound (eg. ulcerating carcinoma) Mental disability Diagnosed skin disease Fever (above 28,5 grades Celcius) Active wound infection Not to be able to adequately fill out questionaire Under 18 years of age Wounds with necrotic tissue

Design outcomes

Primary

MeasureTime frame
Patient related parameters (at time point 0,7,14,21,28 days of treatment) 1. Pijn: - bij aanbrengen QWHET - bij dragen van QWHET - bij verwijderen van QWHET - verschil van pijn tussen wel en niet aangeschakelde QWHET 2. Gebruiksvriendelijkheid: - formaat - beperking in bewegingsvrijheid - duidelijkheid van handleiding Wound consultant (op tijdstip 0,7,14,21,28 dagen behandeling) 1. Is user manual clear 2. Is the device easy to apply 3. are wound pads easy to apply 3. is wound pad easy to apply 4. are the devices easy to remove from sterile packaging 5. are the connectors easy to insert into device 6. is it easy to combine with the standard wound therapy Wound (op tijdstip 0,7,14,21,28 dagen behandeling) 1. is there an allergic reaction to the pads - pad for device - skin pads - wound pad 2. any adverse reaction (op tijdstip 0,7,14,21,28 dagen behandeling) - itching - fever - enlargement wound - exaggerated wound infection - failure to treat wounds for the whole period of 28 days (reason?)

Secondary

MeasureTime frame
Questionnaire for wound consultant (op tijdstip 0,7,14,21,28 dagen behandeling) Does the treatment has any effect on wound healing: - size - deepness of wound - vascularisation - pain - irritation

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)