Myka is a Medical Statistician in Surgical Interventions, Devices and Diagnostics Division at Leeds Institute for Clinical Trials Research.

She has experience in pragmatic trials investigating strategies for treating wound healing (diabetic foot ulcers), autoimmune diseases (psoriatic arthritis, Sjögren’s syndrome), musculoskeletal conditions (distal upper limb disorders), cardiovascular disease, liver disease, and bowel disorders (IBS-D).

Presentation at The SoTV/EWMA 2024 Conference, London

Research and data underpinning successful Randomised Control Trial (RCT) design in dermatological surgery: The HEALS2 trial

Learning objectives

After attending this session, persons will be able to:

• Understand current evidence for compression therapy to aid healing of lower limb secondary intention wounds
• Learn about healing time for lower limb secondary intention wounds and factors affecting healing post-surgery
• Describe the process and feasibility required to develop a funded NIHR Randomised Controlled Trial in skin cancer surgery
• Learn how patient and public involvement played an integral role in our study development

Abstract

Aim: We describe the pathway taken by dermatology surgeons and researchers to a successful RCT design and NIHR funding. HEALS2 is a multicentre RCT comparing the clinical and cost-effectiveness of standard care(SC) vs. SC + compression therapy(CT) in wounds healing by secondary intention(HBSI) in patients undergoing excision of keratinocyte cancer(KC) on the lower limb.

Methods: We demonstrated:

1. evidence of an efficacy signal from the intervention
2. clinician equipoise
3. patient acceptability
4. feasibility

This was achieved through: evidence review(1,2); Dermatologists’ survey(3); patient and carer focus group and; cohort study(4, 5).

Results:

Reviews: Effectiveness of CT demonstrated in venous leg ulcers(1). No trial evidence found for lower limb KC excision(2).

Survey: 109 dermatologists indicated median 5 lower limb KC excisions/month/centre, 48% wounds HBSI and clinical equipoise(3).

Focus group: n=8 identified time to healing, complications and quality of scar/healing as important outcomes and design allowing both bandages and hosiery.

Feasibility cohort: 58 participants, median time to healing of 81 days (SC arm)(4, 5) informing RCT sample size estimate: 396 participants(198 per group) for 90% power; 30% reduction in time to healing.

Conclusions: We hope our journey to successful RCT funding will inspire other clinical researchers to develop research ideas with potential to improve patient outcomes.

Acknowledgement: 2014 UK DTN trainee programme funding   |   HEALS2 trial is funded by NIHR HTA