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NCT02237287 Clinical Trial

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

Pressure Ulcer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02237287
Other study ID # 2010-MD-0007
Secondary ID
Status Terminated
Phase Phase 0
First received August 18, 2014
Last updated September 28, 2015
Start date February 2011
Est. completion date August 2012

Study information
Verified date September 2015
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 24
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• wound dressing with VAC and sNAG without antiaggregation

Procedure:
• wound dressing with VAC

Drug:
• wound dressing with VAC and sNAG under Antiaggregation

Locations
Country Name City State
Switzerland University Hospital Basel Basel
Switzerland Swiss Paraplegic Centre Nottwil Nottwil

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland Marine Polymer Technologies, Inc.

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events as a Measure of Safety and Tolerability up to 1 year Yes
Primary Wound surface area increase, respectively decrease as a measure of the effect of the studied devices on pressure ulcer healing up to 1 year No
Secondary Wound Healing characteristics Evaluation of granulation tissue formation in study groups up to 1 year No
Secondary Wound Healing characteristics Evaluation of wound epithelialization in study groups up to 1 year No
Secondary Wound Healing characteristics Evaluation of wound contraction in study groups up to 1 year No
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