Combination of Taliderm® and Vacuum-assisted Closure (VAC) for Treatment of Pressure Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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Combination of Taliderm® and VAC for Treatment of Pressure Ulcers - a Pilot Study

Conditions
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Wounds, Pressure Ulcer

Intervention / Treatment
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* Other: wound dressing with VAC and sNAG without antiaggregation
* Procedure: wound dressing with VAC
* Drug: wound dressing with VAC and sNAG under Antiaggregation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: wound dressing with VAC<br>After wound debridement wounds are treated for 2 weeks with VAC dressing alone | Procedure: wound dressing with VAC<br> <br> |
| Other: wound dressing with VAC and sNAG under Antiaggregation<br>In patients being under antiaggregation with Aspirin® 100mg daily, after wound debridement wounds are treated with VAC and sNAG | Other: wound dressing with VAC and sNAG without antiaggregation<br> <br> Procedure: wound dressing with VAC<br> <br> Drug: wound dressing with VAC and sNAG under Antiaggregation<br> <br> |
| Experimental: wound dressing with VAC and sNAG without antiaggregation<br>In patients NOT being under antiaggregation, after wound debridement wounds are treated with VAC and sNAG | Other: wound dressing with VAC and sNAG without antiaggregation<br> <br> Procedure: wound dressing with VAC<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Healing characteristics | Evaluation of granulation tissue formation in study groups | up to 1 year | 
| Wound Healing characteristics | Evaluation of wound epithelialization in study groups | up to 1 year | 
| Wound Healing characteristics | Evaluation of wound contraction in study groups | up to 1 year |