Er:YAG + RecoSMA® Demonstrates Superior Outcomes vs Sharp Debridement in Randomised Clinical Trial

Published in the International Wound Journal

We are proud to announce the publication of a prospective randomised controlled trial evaluating high-intensity Er:YAG laser therapy with RecoSMA® technology versus conventional sharp debridement for the treatment of chronic lower-extremity ulcers.

The study, published in the International Wound Journal, included 144 patients with diabetic foot ulcers, venous leg ulcers, and arterial ulcers.

Study Overview

The trial compared two approaches:

• Treatment group (n=71): High-intensity Er:YAG laser ablation followed by RecoSMA® regenerative mode
• Control group (n=73): Conventional sharp surgical debridement

Baseline wound characteristics, duration, aetiology, and comorbidities were comparable between groups.
The primary endpoints included:

• Time to clean the wound bed
• Time to granulation
• Marginal and complete epithelialisation
• Percentage wound area reduction
• Bacterial clearance
• Cytological wound progression

Key Clinical Findings

1️⃣ Significantly Higher Wound Closure Rate

After 30 days:

• 56.3% of wounds in the laser group achieved complete epithelialisation
• Compared to 26% in the control group
• (p < 0.001)

This represents more than a twofold increase in full wound closure.

2️⃣ Faster Wound Bed Preparation

Laser-treated wounds demonstrated:

• Earlier detritus clearance
• Faster granulation tissue formation
• Earlier marginal epithelialisation

3️⃣ Greater Reduction in Wound Area

At day 30:

• 79% average percentage wound area reduction (PWAR) in the laser group
• Compared to 58% in the control group

Among diabetic foot ulcers, the average PWAR reached 84%.

4️⃣ Enhanced Bacterial Clearance

By day 15:

• 67.6% of laser-treated wounds showed no bacterial growth
• Compared to 46.5% in the control group
• (p < 0.001)

This supports the laser’s ability to disrupt biofilms and reduce microbial burden.

5️⃣ Regenerative Cytological Shift

Cytology analysis revealed:

• Higher proportion of regenerative cells in the laser group
• Lower persistence of inflammatory cell dominance

At day 30, regenerative cytograms were substantially more prevalent in the treatment group.

6️⃣ High Tolerability

Laser debridement was reported as painless in:

• 69% of patients in ablation mode
• 100% of patients in RecoSMA® mode

No adverse events were reported.

Why This Matters

Chronic wounds are frequently stalled by:

• Biofilm persistence
• Non-viable tissue
• Prolonged inflammatory dominance
• Impaired microcirculation

This study demonstrates that high-intensity Er:YAG laser therapy combined with RecoSMA® technology offers:

• Precise removal of necrotic tissue
• Biofilm disruption
• Stimulation of neovascularisation
• ECM remodeling
• Anti-fibrotic biological activation

Without adding secondary thermal damage to fragile tissue.

A Step Forward in Regenerative Wound Management

The findings suggest that Er:YAG laser therapy in ablation + RecoSMA® mode is a clinically effective and safe alternative to conventional sharp debridement for chronic lower limb ulcers. This publication reinforces the growing body of evidence supporting regenerative laser-based wound management strategies.