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

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02237287
• Collaborator: Marine Polymer Technologies, Inc. (Industry)
• Enrollment: 24
• Locations: 2
• Arms: 3
• Duration (Months): 18
• Patients Per Site: 12
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Wounds; Pressure Ulcer	Other: wound dressing with VAC and sNAG without antiaggregation; Procedure: wound dressing with VAC; Drug: wound dressing with VAC and sNAG under Antiaggregation	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Combination of Taliderm® and VAC for Treatment of Pressure Ulcers - a Pilot Study
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

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	Other: wound dressing with VAC and sNAG without antiaggregation; Procedure: wound dressing with VAC; 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	Other: wound dressing with VAC and sNAG without antiaggregation; Procedure: wound dressing with VAC

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [up to 1 year]

2. Wound surface area increase, respectively decrease as a measure of the effect of the studied devices on pressure ulcer healing [up to 1 year]

Secondary Outcome Measures

1. Wound Healing characteristics [up to 1 year]

   Evaluation of granulation tissue formation in study groups

2. Wound Healing characteristics [up to 1 year]

   Evaluation of wound epithelialization in study groups

3. Wound Healing characteristics [up to 1 year]

   Evaluation of wound contraction in study groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Basel	Basel		Switzerland	4031
2	Swiss Paraplegic Centre Nottwil	Nottwil		Switzerland	6207

Sponsors and Collaborators

• University Hospital, Basel, Switzerland
• Marine Polymer Technologies, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT02237287
• Other Study ID Numbers: 2010-MD-0007
• First Posted: Sep 11, 2014
• Last Update Posted: Sep 29, 2015
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Pressure Ulcer; Ulcer

Study Results

No Results Posted as of Sep 29, 2015