Venous Leg Ulcer
Conditions
Keywords
maceration, bacterial cellulose dressing, PHMB, antimicrobial dressing
Brief summary
This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers.
Detailed description
During the screening, all patients will be assessed for inclusion and exclusion criteria and wound exudation status. Eligible patients with slight or moderate wound exudation will be randomly assigned to treatment with either Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB. The patients who fulfil all other eligibility criteria but have high level of wound exudation will enter a 7-days run-in period, during which they will receive superabsorbent dressing (e.g. Vliwazell® Pro, Vliwasorb® Pro) and monitored compression therapy with Rosidal® 1C. During the run-in period they should receive appropriate treatment including systemic antimicrobial drug therapy if required. After this time, these patients should be re-assessed and in case they still fulfil all eligibility criteria, and the exudation decreased at least to a moderate level, they will be randomised to Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB. In case the exudation would not decrease within this period or other eligibility criteria are not met anymore, they will be screened out. Upon randomisation, all patients will receive the assigned dressing for 21 (±2) days, or till the complete epithelialization, if it occurs earlier. The patients should also continue to receive adequate compression and, if necessary, systemic antimicrobial drug therapy. During the study participation, selected parameters of the wound will be assessed at Baseline, Interim Visit, and EOT visit. In addition, dressing changes may be performed in-between on as needed basis. After 3 weeks of treatment with Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB, all patients will complete the study. Their further treatment (if necessary), will not be the part of the study.
Interventions
DEVICEPHMB-impregnated biocellulose wound dressing with additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)
Application of a wound dressing with additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy.
DEVICEPHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)
Application of a wound dressing without additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy.
Sponsors
Lohmann & Rauscher
Clean Data Labs
Sphera Clinical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Primary endpoint ans some secondary endpoints will be re-confirmed by a blinded assessment of the wound photographs
Intervention model description
Patients will be randomised to Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB in a 1:1 ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Infected\* venous\*\* leg ulcer * Slightly to moderately exuding wound\*\*\* * Patient has signed informed consent * as per CDC definition, also TILI score ≥ 5 \*\* ABPI \> 0.8 and \< 1.2 \*\*\* patients with highly exuding wounds may be screened for a 7 days run-in period to receive superabsorbent dressing and monitored compression therapy and re-con-sidered for enrolment in case the exudation level decreases
Exclusion criteria
* Participation in other interventional clinical trial that could interfere with the present study within 4 weeks of the randomisation and during the whole duration of this study * Wounds with exposed cartilage tissue (hyaline cartilage) * Contraindications to compression therapy (e.g.: advanced peripheral ar-terial occlusive diseases, decompensated cardiac insufficiency, septic phlebitis, phlegmasia coerulea dolens, sensation disorders of the skin) * Known allergy and/or hypersensitivity to any components of the study product or concomitant products (e.g. compression bandage) * Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and / or interpreta-tion of the study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate and severity of maceration after 3 weeks of treatment with Suprasorb®X+PHMB (Pro) | 3 weeks | on a 4-grade scale there 0 means no maceration and 4 means severe maceration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound area change over time | 3 weeks | in mm2 |
| Change of necrotic & fibrinous & granulation tissue rate in the wound bed | 3 weeks | in % |
| Change of wound infection status | 3 weeks | by a TILI (Therapeutical Index for Local Infections) score with a range 1-6. TILI \< 5 indicates a wound without infection, whereas TILI ≥ 5 means a local wound infection. |
| Product safety (rate of product-related complications) | 3 weeks | by rate of product-related complications |
| Change of wound exudation and presence of peri-wound oedema | 3 weeks | by the investigators' assessment of exudation grade |
| Change in patient's pain | 3 weeks | By NRS (numeric rating scale), with zero meaning "no pain" and 10 meaning "the worst pain imaginable" |
| Product usability | 3 weeks | by user and patient questionnaire |
| Change in patient's quality of life | 3 weeks | by Wound QoL-17 (wound quality of life) questionnaire |
| Oedema chamge | 3 weeks | by measurement of limb circumference |
| Sub-bandage pressure levels retention | 3 weeks | difference of the pressure levels, measured at the time of application and before the next dressing change with a wireless sensor |
Countries
Poland
Contacts
CONTACTDaria Trofimenko, MD
PRINCIPAL_INVESTIGATORKonrad Pańczak, MD
LECRAN - CENTRUM OPIEKI NAD RANAMI-KUNICKIEGO
Outcome results
None listed