L97 S91
Conditions
Interventions
Group 1: Patients with venous leg ulcer (part A) or split-thickness donor sites (part B) will be treated with the wound dressing HydroClean. The application and dressing change will be performed accor
Sponsors
Paul Hartmann AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Part A, chronic venous leg ulcer: • Patient is 18 years of age or older and has given formal written consent. • Patient suffers from Ulcus cruris venosum (positive venous reflux testing, e.g. ultrasound). • Target ulcer size is between 5cm2 and 50cm2. • Target ulcer persists since min. 3 and max. 36 months • Wound surface is covered with yellow fibrin deposits by 40% or more. Wound is in need for cleansing/wound bed preparation. • Ankle-brachial pressure index (ABPI) is between 0.8 and 1.05 • Patient is suitable for and agrees to use compression therapy (PütterPro2) for the study duration and was using compression therapy before study inclusion. • Patient is able to walk in conjunction to compression therapy. Ankle mobility is fully mobile to limited mobile. Part B, acute wounds: • Patient is 18 years of age or older and has given formal written consent. • Patient underwent a split-thickness skin harvesting procedure within the last 24 h and needs dressing for the donor site wound. • Split-thickness donor site wound size is between 5cm2 and 50cm2.
Exclusion criteria
Exclusion criteria: Part A, chronic wounds: • Known allergies/hypersensitivity or intolerance to any of the study product ingredients. • According to physician’s assessment, the patient is not able to follow the study protocol (e.g. due to cognitive disease) or is not able to understand state, nature, meaning and consequences of the study. • According to physician’s assessment, the patient’s general condition does not allow participation or makes it unlikely to take part in the study for the treatment period of 12 weeks. • Patients with hypertensive leg ulcers (Ulcus cruris hypertonicum Martorell). • Patient suffers from septic phlebitis, severe deep vein thrombosis (phlegmasia cerulea dolens) or other conditions posing a contraindication for compression therapy according to established guidelines and local procedures (e.g. significant sensory neuropathy). • Patient suffers from decompensated heart insufficiency (NYHA Class IV, ACC.AHA Stage D). • Patient suffers from poorly controlled diabetes mellitus (HbA1c 10 mg prednisolone equivalent/day) and/or other immunosuppressive and/ or chemotherapy. • Wound is caused by malign tumor (primary or metastasis). • In addition to study product, further products in direct contact to wound surface will be used. • The target ulcer was treated with HydroClean® during the last four weeks before study start. • Participation in this study or any other study in the last four weeks before beginning of this study. • Female patients of childbearing age, pregnancy (suspected or confirmed), or breast-feeding women Part B, acute wounds: • Known allergies/hypersensitivity or intolerance to any of the study product ingredients. • According to physician’s assessment, the patient is not able to follow the study protocol (e.g. due to cognitive disease) or is not able to understand state, nature, meaning and consequences of the study. • Coagulation disorders • Active wound infection treated with systemic antibiotics • Patient suffers from significant malnutrition with reduced serum albumin levels • Patient suffers from active autoimmune disease requiring corticosteroid treatment (> 10 mg prednisolone equivalent/day) and/or other immunosuppressive and/ or chemotherapy. • Patient suffers from severe dysfunction of liver or kidney (e.g. clinically relevant liver fibrosis, cirrhosis, prolonged prothrombin time, decreased albumin levels) and/ or kidney disease (e.g. clinically relevant increase in serum creatinine, significant proteinuria, requirement for hemodialysis). • Female patients of childbearing age, pregnancy (suspected or confirmed), or breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The correlation of the biochemistry of wound exudate with wound healing properties (clinical signs of inflammation, granulation tissue formation, epithelialization) in the course of HydroClean® treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| • Relative wound area reduction, WAR, WAR =40 %, WAR = 60% • Wound healing/ closure • Development of granulation tissue over time (cleansing activity) • Changes in wound pain, pain during dressing change • Changes in perilesional skin wound borders • Number of product related adverse events • Experience with the application of HydroClean® in combination with compression therapy | — |
Countries
Poland
Contacts
Public ContactWiebke Schröder
Paul Hartmann AG
Outcome results
None listed