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

September 28, 2015 updated by: University Hospital, Basel, Switzerland

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel
      • Nottwil, Switzerland, 6207
        • Swiss Paraplegic Centre Nottwil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: wound dressing with VAC
After wound debridement wounds are treated for 2 weeks with VAC dressing alone
Procedure: wound dressing with VAC
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
Procedure: wound dressing with VAC
Other: wound dressing with VAC and sNAG without antiaggregation
Drug: wound dressing with VAC and sNAG under Antiaggregation
EXPERIMENTAL: wound dressing with VAC and sNAG without antiaggregation
In patients NOT being under antiaggregation, after wound debridement wounds are treated with VAC and sNAG
Procedure: wound dressing with VAC
Other: wound dressing with VAC and sNAG without antiaggregation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: up to 1 year
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
up to 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Marine Polymer Technologies, Inc.

Investigators

  • Study Director: Dirk J. Schaefer, Prof.Dr., University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

August 18, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (ESTIMATE)

September 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-MD-0007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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