Our aim is to determine whether Wireless Micro Current Stimulation accelerates wound healing in chronic wounds as well as surgical wounds healing by secondary intention, as compared to standard treatment. Furthermore, by usage evaluation we intend…
ID
Source
Brief title
Condition
- Other condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Health condition
Wondzorg
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our main study parameter will be the monthly wound area reduction during the
maximum study related treatment of three months. Secondary outcomes are: days
upon full epithelisation of the wound surface, pain reduction, complications
compared to contemporary wound therapies, Patient Related Outcome Measure and a
cost analysis on nursing costs and dressing.
Secondary outcome
Secondary outcomes are: days upon full epithelisation of the wound surface,
pain reduction, complications compared to contemporary wound therapies, Patient
Related Outcome Measure and a cost analysis on nursing costs and dressing.
Background summary
Wireless Micro Current Stimulation (WMCS) is a new method within Electric
Stimulation (ES) therapy. It allows contactless wound treatment and stimulates
the healing process through the induction of the natural wound current. It uses
the capacity of nitrogen and oxygen to donate electrons, thereby surpassing
expensive and cumbersome electrodes and devices. This simple noninvasive
technology has had astounding results in recent studies and is assumed not only
to have a huge potential to recalcitrant wounds but also to treat chronic
wounds generally. It could prove to have a transformative effect on the
treatment of chronic wounds and burns with significant cost reduction.
Study objective
Our aim is to determine whether Wireless Micro Current Stimulation accelerates
wound healing in chronic wounds as well as surgical wounds healing by secondary
intention, as compared to standard treatment. Furthermore, by usage evaluation
we intend to ascertain whether WMCS could be applied in an outpatient
environment due to potentially similar effectiveness across varying treatment
times.
Study design
This study will be a prospective randomised controlled trial conducted within
Bronovo Hospital and Sophia Revalidatie, The Hague and may extend to include
Medisch Centrum Haaglanden, The Hague.
Intervention
Patients randomised to WMCS will receive treatment thrice weekly for 45 minutes
per session. In case of a chronic wound an extra randomisation takes place to
vary the treatment algorithm once weekly for 45 minutes, twice weekly for 45
minutes, thrice weekly for 45 minutes or thrice weekly for 30 minutes. Patients
are otherwise treated with the same dressings and intervals as they would have
done, or as if they had been randomised to the control group.
Study burden and risks
During the start of the therapy patients may report a minimal burning sensation
or itch at the treatment area, but no side effects or complications have been
reported. Pain medication has never been administered within the recent studies
and no change of the surrounding healthy tissue has been observed.
Bronovolaan 5
Den Haag 2597 AX
NL
Bronovolaan 5
Den Haag 2597 AX
NL
Listed location countries
Age
Inclusion criteria
Age of 18 years and older
Mentally competent
Signed the informed consent form
Secondary healing surgical wound or chronic wound as defined:
o Acute: natural intended closure of a surgical/traumatic wound, for example post-operative pilodinal sinuses, split skin grafts (SSG), second degree burns, dehiscent wounds or contaminated cutting wounds at the E.R. with conventional wound care methods during follow-up.
o Chronic: wounds existing over six weeks with a biological or physiological reason for stagnation of the healing process, such as diabetic ulcers, arterial or venous ulcers or decubitus
Exclusion criteria
- Pregnancy
- (Cardial) Implanted electrical device
- (Skin)malignancy within the therapeutic range.
- Epilepsy
- Overshoot granulation tissue of the wound
- Severe woundinfection
- Any treatment with metal ion-containing wound care products
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL50699.098.14 |