A pilot study to investigate the relative effectiveness and safety of chemical wound debridement and curettage in the treatment of venous and mixed aetiology leg ulcers.
A pilot study to investigate the relative effectiveness and safety of chemical wound debridement versus the curettage wound debridement in the treatment of venous and mixed aetiology leg ulcers in the United Kingdom
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
The chemical debridement is a dehydrating agent in a gel shape that will dry out the woundbed and biofilm.
The use of a currette will clean the wound bed. Debridement by mechanically removing the necrotic tissue and biofilm. This is performed confrom the standard of care standards.
Pioneer wound healing and lymphedema centres
Eastbourne, United Kingdom
Wound surface
Change in wound surface area (cm\^2)
Time frame: 12 weeks
Wound Debris
Change in the percentage of the wound bed covered with slough
Time frame: 12 weeks
Wound healing
Number of healed wounds, according BWAT score ranging from 13 (minimal) - 65 (extreme severity)
Time frame: 12 weeks
wound condition
Condition of the wound bed by percentage of granulation tissue, percentage covered in slough, exudate; Measured via visual assessment totalling up to 100% (e.g. 30% granulation, 25% slough, 25% necrosis, 20% exudate)
Time frame: 12 weeks
Quality of Life
Health-related quality of life assessed using WoundQOL (an established validated questionair production a single number between 0-1 with 1 being the optimal quality of life)
Time frame: 12 weeks
Patient Comfort in treatment process
Pain measured Participant pain measured using Visual Analogue Scale (VAS 0-10, 0 being painless and 10 being most pain to be imagined)
Time frame: 12 weeks
Device Safety
Incidence of Treatment-related Adverse Events Incidence of Adverse Events of Special Interest
Time frame: 12 weeks
Treatment Comfort in performance and acceptance
Participant and staff acceptance of the debridement methods by questionnaire. Score denoted in precentage with 100% being fully comfortable and accepted.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 weeks
wound condition
Condition of peri-ulcer skin and surrounding skin (healthy, bumpy, integrated, fragile))
Time frame: 12 weeks
wound condition
Maloudour (yes, no);
Time frame: 12 weeks