Study of two local wound therapy concepts
| ISRCTN | ISRCTN16663820 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16663820 |
| Secondary identifying numbers | GS1-EK-3/183/2021 |
- Submission date
- 11/12/2023
- Registration date
- 31/01/2024
- Last edited
- 22/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
This study is a national research project where we'll be comparing two different ways of treating wounds to see which one is better at cleaning them. The study is designed to be fair and unbiased, and it won't involve any new treatments or placebos. We're focusing on how well each approach reduces the amount of slough in wounds.
Who can participate?
All people age 18 to 85 years with chronic wounds of the following entities:
Ulcus cruris venosum
Ulcus cruris mixtum
Diabetic neuropathic foot ulceration
What does the study involve?
The study comprises 28 days of randomised treatment with either Actimaris solution and gel or Microdacyn solution and gel.
Further wound treatment is based on the standard of the centre. The treatment corresponds to the valid standards of care.
What are the possible benefits and risks of participating?
By participating in the study, the patient receives an unrestricted causal wound-specific and local treatment that fully corresponds to the current state of the art and medical knowledge. Participation will contribute to a systematic collection of data on the effectiveness and tolerability of appropriate products for wound irrigation and wound cleansing (solutions and gels) in a direct comparison.
As this is an established and particularly gentle wound cleansing procedure, no adverse effects are to be expected from these activities. Due to the use of the study products within the scope of their certified intended purpose, no particular risks are associated with participation in the study.
Where is the study run from?
Landesklinikum Wiener Neustadt (Austria)
Wound Competence Centre (Austria)
When is the study starting and how long is expected to run for?
Who is funding the study?
ActiMaris AG (Switzerland)
Who is the main contact?
Dr Thomas Eberlein, thomaseberlein@hotmail.com
Contact information
Public, Scientific, Principal Investigator
Lionstraße 5
Leipzig
04177
Germany
 ORCID ID |
0000-0002-0244-0558 |
|---|---|
| Phone | +49-173-2012299 |
| thomas.eberlein@ihm.ac.at |
Study information
| Study design | Randomized investigator-blinded non-interventional non-placebo-controlled national clinical comparative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Demonstration of the physical wound cleansing performance of Actimaris sensitive solution and gel as well as Microdacyn solution and gel based on the reduction of wound debris |
| Study hypothesis | Objective demonstration of the physical wound cleansing performance of Actimaris sensitive wound irrigation solution and Actimaris gel as well as Microdacyn Solution and Microdacyn Gel. Hypothesis: Both wound irrigation solutions are able to remove yellowish fibrinoid coatings / debris by half the surface area within 4 weeks. |
| Ethics approval(s) |
Approved 18/10/2021, Ethikkommission Für Das Bundesland Niederösterreich (Landhausplatz 1, St. Pölten, 3109, Austria; +43 2742/9005-12731; post.ethikkommission@noel.gv), ref: GS1-EK-3/183/2021 |
| Condition | Objective demonstration of the physical wound cleansing performance of two local therapy concepts |
| Intervention | 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 performance (whereby it is assumed that both concepts are able to reduce yellowish fibrinous adherent coatings by half the area within 4 weeks). Randomisation is carried out by random selection into two groups using sealed, completely opaque envelopes. Patients are treated with either Actmaris solution and gel or Microdacyn solution and gel. The following methodology applies to both study arms: After removing the dressing, the wet phase is carried out (according to Gerhard Kammerlander): Application of at least two gauze compresses, saturated wet with the test product "solution" and covered with at least one non-soaked gauze compress 15 minutes application time Remove the compresses and clean the wound mechanically with gauze compresses moistened with the respective test product. The "wound gel" test product is then applied to the wound surface and covered with a hydrofibre product (Aquacel extra or Biosorb Gelling Fibre Dressing) The choice of wound covering is made according to exudation and the decision of the attending physician (best standard of care of the centre) The total treatment period is 28 days. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 01/02/2019 |
| Overall study end date | 30/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 100 |
| Participant 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 |
| Participant exclusion criteria | 1. Pure PAOD-related ulceration 2. Purely lymphological entities 3. Acute wounds 4. Chronic wounds with signs of infection 5. Age <18, > 85 years 6. Allergy to one or more of the substances used 7. Pregnancy and breastfeeding 8. Inability to adequately participate in the study |
| Recruitment start date | 15/04/2021 |
| Recruitment end date | 30/06/2024 |
Locations
Countries of recruitment
- Austria
Study participating centre
Wiener Neustadt
2700
Austria
Sponsor information
Industry
Dr. Thomas Eberlein
Lionstr. 5
Leipzig
04177
Germany
| Phone | +49 1732012299 |
|---|---|
| thomas.eberlein@ihm.ac.at |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/08/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a per-reviewed journal with focus on wound medicine |
| IPD sharing plan | The datasets generated during the current study will be available upon request from Dr Thomas Eberlein (thomaseberlein@hotmail.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 20/07/2020 | 22/01/2024 | No | No |
Additional files
Editorial Notes
22/01/2024: Trial's existence confirmed by Ethikkommission Für Das Bundesland Niederösterreich.
