RecruitingPhase 4ACTRN12619001174178

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.


Sponsor

Dr Chris Delaney

Enrollment

56 participants

Start Date

Sep 16, 2019

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Minor amputations of toes or part of the foot are sometimes necessary in people with diabetes or other conditions causing poor circulation and infection. After these procedures, wounds are often left open to heal naturally — a process that can be slow and prone to infection. This study tests whether a special wound dressing called Promogran Prisma (which contains oxidised cellulose, collagen, and silver) can reduce infection rates, speed healing, and reduce how often dressings need to be changed compared to standard wound care. All participants are people who have had a minor foot amputation at Flinders Medical Centre with a wound left open to heal. They receive the Promogran Prisma dressing and are followed up at regular intervals to track healing progress, infection, and how often dressings need changing. You may be eligible if you are 18 or older and have recently had a minor amputation involving one or more toes or part of the foot at Flinders Medical Centre, with the wound left open. People who live too far away to attend follow-up appointments, those with a known allergy to the dressing components, or those whose wound was surgically closed are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 ma

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.


Locations(1)

Flinders Medical Centre - Bedford Park

SA, Australia

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ACTRN12619001174178