Combination of Taliderm® and VAC for Treatment of Pressure Ulcers - a Pilot Study
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
wound dressing with VAC
After wound debridement wounds are treated for 2 weeks with VAC dressing alone
Intervention: wound dressing with VAC (Procedure)
wound dressing with VAC and sNAG without antiaggregation
In patients NOT being under antiaggregation, after wound debridement wounds are treated with VAC and sNAG
Intervention: wound dressing with VAC and sNAG without antiaggregation (Other)
wound dressing with VAC and sNAG under Antiaggregation
In patients being under antiaggregation with Aspirin® 100mg daily, after wound debridement wounds are treated with VAC and sNAG
Intervention: wound dressing with VAC and sNAG without antiaggregation (Other)
wound dressing with VAC and sNAG under Antiaggregation
In patients being under antiaggregation with Aspirin® 100mg daily, after wound debridement wounds are treated with VAC and sNAG
Intervention: wound dressing with VAC and sNAG under Antiaggregation (Drug)
wound dressing with VAC and sNAG under Antiaggregation
In patients being under antiaggregation with Aspirin® 100mg daily, after wound debridement wounds are treated with VAC and sNAG
Intervention: wound dressing with VAC (Procedure)
wound dressing with VAC and sNAG without antiaggregation
In patients NOT being under antiaggregation, after wound debridement wounds are treated with VAC and sNAG
Intervention: wound dressing with VAC (Procedure)
Outcomes
Primary Outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: up to 1 year
Wound surface area increase, respectively decrease as a measure of the effect of the studied devices on pressure ulcer healing
Time Frame: up to 1 year
Secondary Outcomes
- Wound Healing characteristics(up to 1 year)