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

Primary Purpose

Wounds, Pressure Ulcer

Status
Terminated
Phase
Early Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
wound dressing with VAC and sNAG without antiaggregation
wound dressing with VAC
wound dressing with VAC and sNAG under Antiaggregation
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Basel
  • Swiss Paraplegic Centre Nottwil

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Other

Experimental

Arm Label

wound dressing with VAC

wound dressing with VAC and sNAG under Antiaggregation

wound dressing with VAC and sNAG without antiaggregation

Arm Description

After wound debridement wounds are treated for 2 weeks with VAC dressing alone

In patients being under antiaggregation with Aspirin® 100mg daily, after wound debridement wounds are treated with VAC and sNAG

In patients NOT being under antiaggregation, after wound debridement wounds are treated with VAC and sNAG

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Wound surface area increase, respectively decrease as a measure of the effect of the studied devices on pressure ulcer healing

Secondary Outcome Measures

Wound Healing characteristics
Evaluation of granulation tissue formation in study groups
Wound Healing characteristics
Evaluation of wound epithelialization in study groups
Wound Healing characteristics
Evaluation of wound contraction in study groups

Full Information

First Posted
August 18, 2014
Last Updated
September 28, 2015
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Marine Polymer Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02237287
Brief Title
Combination of Taliderm® and Vacuum-assisted Closure (VAC) for Treatment of Pressure Ulcers
Official Title
Combination of Taliderm® and VAC for Treatment of Pressure Ulcers - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Open label study part reduced from n=10 to n=6 because of insufficient number of patients under antiaggregation.
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Marine Polymer Technologies, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds, Pressure Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
wound dressing with VAC
Arm Type
Sham Comparator
Arm Description
After wound debridement wounds are treated for 2 weeks with VAC dressing alone
Arm Title
wound dressing with VAC and sNAG under Antiaggregation
Arm Type
Other
Arm Description
In patients being under antiaggregation with Aspirin® 100mg daily, after wound debridement wounds are treated with VAC and sNAG
Arm Title
wound dressing with VAC and sNAG without antiaggregation
Arm Type
Experimental
Arm Description
In patients NOT being under antiaggregation, after wound debridement wounds are treated with VAC and sNAG
Intervention Type
Other
Intervention Name(s)
wound dressing with VAC and sNAG without antiaggregation
Intervention Type
Procedure
Intervention Name(s)
wound dressing with VAC
Intervention Type
Drug
Intervention Name(s)
wound dressing with VAC and sNAG under Antiaggregation
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
up to 1 year
Title
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 Outcome Measure Information:
Title
Wound Healing characteristics
Description
Evaluation of granulation tissue formation in study groups
Time Frame
up to 1 year
Title
Wound Healing characteristics
Description
Evaluation of wound epithelialization in study groups
Time Frame
up to 1 year
Title
Wound Healing characteristics
Description
Evaluation of wound contraction in study groups
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk J. Schaefer, Prof.Dr.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Swiss Paraplegic Centre Nottwil
City
Nottwil
ZIP/Postal Code
6207
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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