Objective demonstration of the physical wound cleansing performance of two local therapy concepts Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Application of two local therapy concepts (Actimaris sensitive wound irrigation solution and Actimaris gel or Microdacyn solution and Microdacyn gel) to demonstrate the physical wound cleansing perfor
Sponsors
ActiMaris AG Switzerland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with chronic wounds: 1. Ulcus cruris venosum 2. Ulcus cruris mixtum: KADI (ankle-brachial index = 0.7) 3. Diabetic neuropathic foot ulcer (Wagner-Armstrong 1A and 3A) if they are weakly to heavily exuding and superficial to max. 2 cm deep 4. Wound surface area min. 1 cm² 5. Wound age at least 8 weeks 6. Causal cause diagnosed and (re-)treated 7. Wounds show at least a slight odour in the clinical assessment ("slight odour" according to the Odour Assessment Scoring Tool or "odour 1" according to the AVLON scale) 8. At least 50 % of the wound surface shows yellowish (fibrinoid) adherent debris at the time of study inclusion
Exclusion criteria
Exclusion criteria: 1. Pure PAOD-related ulceration 2. Purely lymphological entities 3. Acute wounds 4. Chronic wounds with signs of infection 5. Age 85 years 6. Allergy to one or more of the substances used 7. Pregnancy and breastfeeding 8. Inability to adequately participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The physical cleansing performance (reduction of the wound coating over time) of two therapy concepts is determined over a period of 28 treatment days; measured via quantitative image analysis and clinical blinded assessment at the beginning, after 7, 14, 21 and 28 days of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tolerability (subjective assessment by patient and practitioner [pain/burning/itching] using VAS score at the beginning, after 7, 14, 21 and 28 days of treatment. 2. Odour reduction (subjective assessment by the practitioner using the four-stage odour assessment scoring tool (OAST)) at the beginning, after 7, 14, 21 and 28 days of treatment. 3. Reduction of signs of inflammation (subjective assessment by the practitioner) using the documentation tool at the beginning, after 7, 14, 21 and 28 days of treatment. 4. Clinical biofilm detection (existence and reduction) by means of parameters (existence of a continuous, slimy, milky-transparent film on the wound), after 7, 14, 21 and 28 days of treatment. | — |
Countries
Austria
Contacts
Public ContactThomas Eberlein
Outcome results
None listed