Pressure Ulcer, Wounds
Conditions
Brief summary
Background: The wound healing promoting effect of negative wound pressure therapies (NWPT) takes place at the wound foam interface. Implementation of bioactive substances at this site represents a major research area for the development of future NWPT devices. Methods: Wound healing kinetics of pressure ulcers treated by vacuum assisted closure devices with or without the implementation of a thin interface of poly-N-acetyl glucosamine nanofibers (sNAG) was studied in a prospective randomized clinical trial.
Interventions
OTHERwound dressing with VAC and sNAG without antiaggregation
PROCEDUREwound dressing with VAC
DRUGwound dressing with VAC and sNAG under Antiaggregation
Sponsors
Marine Polymer Technologies, Inc.
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ischial/sacral Pressure ulcer between 4 and 15cm diameter * Greater than or equal to 18 years of age * Ability to obtain informed consent
Exclusion criteria
* Connective tissue disorders * Immunosuppression, Hemodialysis, Steroids * Pregnancy * Sepsis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | up to 1 year |
| Wound surface area increase, respectively decrease as a measure of the effect of the studied devices on pressure ulcer healing | up to 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing characteristics | up to 1 year | Evaluation of granulation tissue formation in study groups |
Countries
Switzerland
Outcome results
None listed