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Clinical trial report - design

Trial Design

  • Visit 1 - Baseline visit

  • Visit 2 - 28 days later Patients with
    non-healing wounds started on the Synapse Accel-Heal® unit

  • Visit 3 - 10 days later treatment with the Synapse Accel-Heal® unit stopped

  • Visit 4 - 10 days later Final assessment

  • Visit 5 - Trial extended a further 3 months follow-up to see positive wound change

  • Assessment

  • Results

  • Conclusions

  • Case Study 1

  • Case Study 2

  • Case Study 3

*TVCS - Tissue Viability Consultancy Services

This trial was carried out at TVCS* in Eastbourne on patients with Chronic non-healing wounds. 30 Patients were enrolled onto the trial.

Visit 1 - Baseline visit

Patients identified and consented Photographed Ultrasound scan carried out on wound and surrounding intact periwound skin to establish a baseline. Each patient continued with their current wound management delivered by a tissue viability nurse.

Visit 2

28 days after the baseline visit the wounds were again photographed and scanned. From this, it was possible to ascertain if the wound had responded to the current wound management or had remained as a non-healer. If the wound had shown progress towards healing since visit 1 the patient was excluded from the trial. If the wound had not progressed from the visit 1 status the patient continued on the trial.
Patients continuing on the trial were then started on the Synapse electrical Accel-Heal® unit.

Visit 3

10 days after visit 2 the wounds were photographed and scanned again. At this Point treatment with the Synapse Accel-Heal® unit was stopped and the patient continued with their usual dressing protocol.

Visit 4 - Final assessment

10 days after visit 3 the patients returned for one final assessment. The wounds were photographed and scanned.

Visit 5 - Follow up

Based on the results at visit 4 it was decided to extend the trial to include a 3 month follow-up to see if positive wound changes seen in the trial had been maintained.