Safety and Effectiveness of Negative Pressure Wound Therapy (Avelle) on Venous Leg Ulcers: The SPACE Study

TL;DR

This study shows that using a specific negative pressure wound therapy device for two weeks significantly reduces the size of hard-to-heal venous leg ulcers with a good safety profile.

Contribution

The study provides new clinical evidence on the effectiveness and safety of the Avelle NPWT system for treating venous leg ulcers.

Findings

A 46.8% reduction in wound area was observed after two weeks of NPWT treatment.

Dressing changes were needed in only 6% of patients due to saturation.

No infections were reported, and the device had a good safety profile.

Abstract

Introduction

Hard-to-heal wounds represent a substantial burden on patients’ quality of life and healthcare systems. Negative pressure wound therapy (NPWT) is an advanced therapy used to manage hard-to-heal wounds as an adjunct to standard wound care; however, there are limited data on its clinical effectiveness. The aim of this study was to evaluate the clinical effectiveness and safety of the Avelle NPWT system in hard-to-heal venous leg ulcers (VLUs).

Methods

This was a single-arm, single-center, open-label, prospective study (NCT05666570) conducted in a Colombian outpatient setting. Patients with a venous ulcer, as per Clinical, Etiological, Anatomical, and Pathophysiological (CEAP) Classification C6/C6R, that has not progressed by >30% in the previous 4 weeks were enrolled. Eligible patients received NPWT at the screening/baseline visit (Visit 1) with scheduled follow-up visits on Day 6 ± 1 (Visit 2) and Day 13 ± 1 (Visit 3; end of study). The primary endpoints were baseline change in wound size and dressing durability. Secondary endpoints included clinical wound characteristics and device-related adverse events.

Results

Fifty-nine patients (median age: 66 years) with VLUs were enrolled (intention-to-treat population). In the per protocol population (n=50), the mean ± standard deviation wound area was 13.4 ± 17.0 cm2 at baseline and 7.3 ± 9.9 cm2 at study completion (46.8% reduction; p<0.001). Median dressing wear time was 6 days, and changes due to dressing saturation were reported in ≤ 3 (6%) patients. One VLU had completely healed. Erythema was the most common peri-wound skin condition at baseline (n=31, 62%) but decreased at the end of the study (n=26, 54%). Throughout the study, ≤ 6 (13%) patients had signs of eczema/dermatitis, hyperkeratotic callus, maceration, or edema, and there were no signs of infection. One patient experienced device-related dermal lesions resulting in study withdrawal, and one patient had a serious adverse event (not related to the device).

Conclusions

Management of hard-to-heal VLUs with NPWT for 2 weeks was associated with a significant reduction in wound size, as well as effective exudate control and a good safety profile. These results, combined with features of the device such as portability and ease of use, suggest it could be an effective treatment option in hard-to-heal wounds.

Figures