What is the effect in reepithelialisation of chronic ulcers using hypochlorous acid solution during 6 weeks.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
What is the effect in reepithelization of chronic ulcers using hypochlorous
acid solution during 6 weeks.
Secondary outcome
The amount of patients with a >50% reepithelialisation at week 6.
• The change in reepithelialisation measured at all visits from baseline till
week 6.
• The reduction in VAS pain score measured at all visits from baseline till
week 6.
• The change in pain score measured at all visits from baseline till week 6.
Background summary
n dermatology practice a large group of patients is suffering from chronic
slow-healing wounds from different origins, like venous diseases but also due
to trauma. One of the characteristics of these wounds is that they are
colonised by bacteria and fungi which inhibit the reepithelialisation and
healing process.
Active chlorine released from hypochlorous acid solution is very effective
against bacteria and candida species at relatively low concentrations.
A decrease of bacterial and fungal load in these chronic slow-healing wounds
has a positive effect on the healing time of these wounds. A fast recovery will
reduce the amount of pain and discomfort experienced by patients. Additionally,
this could result in a reduction of healthcare costs associated with ulcers.
Study objective
What is the effect in reepithelialisation of chronic ulcers using hypochlorous
acid solution during 6 weeks.
Study design
The study will be performed as a single arm interventional study in which ten
patients with chronic ulcer(s) (more than 6 weeks present despite normal wound
care provided by GP or home care)
Study burden and risks
not applicable
H. Dunantweg 2
Leeuwarden 8934 AD
NL
H. Dunantweg 2
Leeuwarden 8934 AD
NL
Listed location countries
Age
Inclusion criteria
leg ulcus consisting over 6 weeks other than exclusivly arterial ulcers
Exclusion criteria
• Age younger than 18 years
• Suffering from somatic or psychiatric disease which makes it impossible to
come to our outpatient clinic
• Suffering from complicating diseases which also interfere with wound healing
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80387.099.22 |