Pre-Clinical Assessment of Single-Use Negative Pressure Wound Therapy During In Vivo Porcine Wound Healing

Abstract

Traditional negative pressure wound therapy (tNPWT) systems can be large and cumbersome, limiting patient mobility and adversely affecting quality of life. PICOÔ, a no canister single-use system, offers a lightweight, portable alternative to tNPWT, with improved clinical performance. The aim of this study was to determine the potential mechanism(s) of action of single-use NPWT (sNPWT) versus tNPWT. Approach: sNPWT and tNPWT were applied to an in vivo porcine excisional wound model, following product use guidelines. Macroscopic, histological, and biochemical analyses were performed at defined healing time points to assess multiple aspects of the healing response. Results: Wounds treated with single-use negative pressure displayed greater wound closure and increased reepithelialization versus those treated with traditional negative pressure. The resulting granulation tissue was more advanced with fewer neutrophils, reduced inflammatory markers, more mature collagen, and no wound filler-associated foreign body reactions. Of note, single-use negative pressure therapy failed to induce wound edge epithelial hyperproliferation, while traditional negative pressure therapy compromised periwound skin, which remained inflamed with high transepidermal water loss; features not observed following single-use treatment. Innovation: Single-use negative pressure was identified to improve multiple aspects of healing versus traditional negative pressure treatment. Conclusion: This study provides important new insight into the differing mode of action of single-use versus traditional negative pressure and may go some way to explaining the improved clinical outcomes observed with single-use negative pressure therapy.

Cellular benefits of single‐use negative pressure wound therapy demonstrated in a novel ex vivo human skin wound model

“…Further, tNPWT‐induced inflammation led to elevated epidermal apoptosis and epidermal‐dermal junction break down, not dissimilar to that observed following pressure injury 39 . Matrix metalloproteinase levels were also higher following tNPWT, as shown in our previous in vivo study, 35 suggesting the potential to contribute to delayed healing via excessive proteolysis of matrix components 40 . Collectively, our ex vivo findings suggest that sNPWT beneficially alters multiple aspects of wound edge physiology vs tNPWT, and this may confer improved clinical efficacy.…”

“…However, these reports have largely focused on the effects of sustained compression and damage at the wound bed: foam filler interface. Retention of wound filler can also increase inflammatory cell influx and promote foreign body reactions 12,34,35 . Our data now suggest the importance of considering wound‐edge epidermal‐derived inflammatory mediators.…”

“…Retention of wound filler can also increase inflammatory cell influx and promote foreign body reactions. 12 , 34 , 35 Our data now suggest the importance of considering wound‐edge epidermal‐derived inflammatory mediators. Indeed, heightened inflammation is a key contributing factor in pathological healing.…”

Wound healing: cellular mechanisms and pathological outcomes

“…Contemporary dressings contain a myriad of material properties to aid tissue repair and incorporate substances with known pro-healing or antimicrobial effects [202,203]. More advanced solutions are available, including the continually evolving negative pressure wound therapy modality [204]. Despite numerous available treatments, current best practice wound management is almost exclusively aimed at addressing secondary causes of chronicity, while also relying heavily on patient compliance.…”

A prospective, randomized, controlled clinical study on the effectiveness of a single‐use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of diabetic ulcers of the lower extremities

“…A recent preclinical study 15 confirmed the results of the clinical trial and found that the s-NPWT used in that study improves multiple aspects of healing versus t-NPWT and promotes faster healing. The area of the wound remaining open, determined as a percentage of day 0 wound area, was significantly smaller following s-NPWT than t-NPWT at both day 6 (70.06% vs. 78.55%; p < 0.001) and day 12 (18.56% vs. 33.36%; p < 0.001) postinjury.…”