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Prisma in minor amputations

A randomised trial of perioperative use of combination oxidized regenerated cellulose, collagen and silver (Promogran Prisma™) dressing in lower limb minor amputations.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001174178
Enrollment
36
Registered
2019-08-20
Start date
2019-09-16
Completion date
2020-12-31
Last updated
2021-01-05

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

Conditions

None listed

Brief summary

We hypothesize that a combination oxidised regenerated cellulose, collagen and silver dressing (Promogran Prisma ™) will be safe to use with an observed reduction in post-operative infection, increased wound healing and decreased frequency of dressing changes for lower limb minor amputation wounds. A positive outcome will result in a change of clinical practice.

Interventions

A randomised control trial designed to test the hypothesis: 1. Promogran Prisma provides improved wound healing in patients who undergo minor amputation of the lower limb. Promogran Prisma is a matrix topical wound dressing composed of 55% bovine derived collagen, 44% oxidised regenerated cellulose (ORC) and 1% silver ORC. Patients will be randomised using a pre-randomised secret envelope system containing random assignment to either control or trial group, available at the time of lower limb

A randomised control trial designed to test the hypothesis: 1. Promogran Prisma provides improved wound healing in patients who undergo minor amputation of the lower limb. Promogran Prisma is a matrix topical wound dressing composed of 55% bovine derived collagen, 44% oxidised regenerated cellulose (ORC) and 1% silver ORC. Patients will be randomised using a pre-randomised secret envelope system containing random assignment to either control or trial group, available at the time of lower limb minor amputation: A trial group who will receive Promogran Prisma ™ as primary dressing, placed into the wound bed post completion of minor amputation, The Promogran Prisma ™ will be covered with absorbent secondary dressings and secured with crepe bandage. The dressing will be reviewed at the 48 hour mark unless otherwise indicated. The patient will continue to use Promogran Prisma ™ as the primary wound dressing and will remain the only variable to standard minor amputation post-operative wound management for a period of 12 weeks. This group will be used to assess the effect of Promogran Prisma™ as a primary wound dressing for minor amputations. Dressings will be applied by the governing surgical team intraoperatively, and then by hospital and community nursing staff post initial intraoperative placement. This follows the current usual standard of care.

Sponsors

Dr Chris Delaney
Lead SponsorIndividual

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
No

Inclusion criteria

All patients undergoing minor amputation of the foot (single or multiple digits, to base of metatarsal as maximum depth debrided / amputated) at Flinders Medical Centre, where the surgical site has been left open to heal via secondary intention.

Exclusion criteria

i. Patients who live interstate, rural or remote or who are not able to attend the scheduled appointed review time frames. ii. Patients under 18 years of age. iii. Patients who are unable to give informed consent due to language difficulties or physical/mental incapacity. iv. A minor amputation where the operative wound bed has been closed using primary closure methods (suture, staples). v. Patients with known hypersensitivity to any components of Promogran Prisma™ - oxidised regenerated cellulose, collagen and silver.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026