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

NCT ID: NCT02237287

Last Updated: 2015-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-08-31

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.

Detailed Description

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Conditions

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Wounds Pressure Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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wound dressing with VAC

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

Group Type SHAM_COMPARATOR

wound dressing with VAC

Intervention Type PROCEDURE

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

Group Type OTHER

wound dressing with VAC and sNAG without antiaggregation

Intervention Type OTHER

wound dressing with VAC

Intervention Type PROCEDURE

wound dressing with VAC and sNAG under Antiaggregation

Intervention Type DRUG

wound dressing with VAC and sNAG without antiaggregation

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

Group Type EXPERIMENTAL

wound dressing with VAC and sNAG without antiaggregation

Intervention Type OTHER

wound dressing with VAC

Intervention Type PROCEDURE

Interventions

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wound dressing with VAC and sNAG without antiaggregation

Intervention Type OTHER

wound dressing with VAC

Intervention Type PROCEDURE

wound dressing with VAC and sNAG under Antiaggregation

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marine Polymer Technologies, Inc.

INDUSTRY

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dirk J. Schaefer, Prof.Dr.

Role: STUDY_DIRECTOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status

Swiss Paraplegic Centre Nottwil

Nottwil, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2010-MD-0007

Identifier Type: -

Identifier Source: org_study_id

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