Health TrialsbyHealthPanel

Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers

ConditionVenous Leg Ulcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLohmann & Rauscher

About this trial

This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Infected* venous** leg ulcer

Slightly to moderately exuding wound***

Patient has signed informed consent

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • PHMB-impregnated biocellulose wound dressing with additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)

    Device

    Application of a wound dressing with additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy.

  • PHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)

    Device

    Application of a wound dressing without additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Suprasorb®X+PHMB ProExperimental treatment 1 intervention
Group B: Suprasorb®X+PHMBActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate and severity of maceration after 3 weeks of treatment with Suprasorb®X+PHMB (Pro)

on a 4-grade scale there 0 means no maceration and 4 means severe maceration

Time frame
3 weeks

Secondary outcomes

1

Wound area change over time

in mm2

Time frame
3 weeks
2

Change of necrotic & fibrinous & granulation tissue rate in the wound bed

in %

Time frame
3 weeks
3

Change of wound infection status

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.

Time frame
3 weeks
4

Product safety (rate of product-related complications)

by rate of product-related complications

Time frame
3 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lohmann & Rauscher

Lead sponsor

Clean Data Labs

Collaborator

Sphera Clinical Research

Collaborator

Source ClinicalTrials.gov
Apply now