Using a biodegradable polyurethane foam in comparison with Granufoam (black, non-biodegradable foam) with Vacuum-Assisted Closure in the management of decubitus ulcers (pressure sores)

Safety and efficacy of vacuum assisted closure with a biodegradable polyurethane foam versus Granufoam in pressure sore sufferers.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000815965

Enrollment

Registered

2011-08-03

Start date

2012-03-04

Completion date

2013-01-24

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Comparison of new biodegradable foam against commercially available non-biodegradable foam under topical negative pressure dressings for safety and efficacy in transmitting the vacuum to the wound bed.

Interventions

New biodegradable polyurethane foam under topical negative pressure in standard treatment regimen (foams changed every 2-3 days) for 8 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Ischial or sacral pressure sore; >18 years old; suitable for topical negative pressure after wound debridement; able to provide informed consent

Exclusion criteria

Pregnancy; inability to provide informed consent

Outcome results