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

University Hospital Basel

Status and phase: Terminated; Early Phase 1

Conditions: Pressure Ulcer; Wounds

Treatments: Other: wound dressing with VAC and sNAG without antiaggregation; Drug: wound dressing with VAC and sNAG under Antiaggregation; Procedure: wound dressing with VAC

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02237287

2010-MD-0007

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups

wound dressing with VAC

Sham Comparator group

Description:

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

Treatment:

Procedure: wound dressing with VAC

wound dressing with VAC and sNAG under Antiaggregation

Other group

Description:

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

Treatment:

Drug: wound dressing with VAC and sNAG under Antiaggregation

Other: wound dressing with VAC and sNAG without antiaggregation

Procedure: wound dressing with VAC

wound dressing with VAC and sNAG without antiaggregation

Experimental group

Description:

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

Treatment:

Other: wound dressing with VAC and sNAG without antiaggregation

Procedure: wound dressing with VAC