Fasciotens® for abdominal wall closure: current evidence and clinical perspectives.

Clinical Snapshot

Key Findings

• P Value: Not reported

• Effect Size: Described qualitatively as 'high rates of primary fascial closure' and 'shorter time to closure'; no quantitative effect size reported

• Primary Outcome: Primary fascial closure rate in patients with open abdomen or complex ventral hernias treated with Fasciotens® vertical fascial traction device

• Nnt Or Sensitivity: Not calculable from available data; no comparative group or control arm present in the included studies to derive NNT or relative risk estimates

• Confidence Interval: Not reported; no meta-analytic pooling performed

Clinical Application

The device appears technically feasible based on the available case series evidence, with device-related adverse events described as 'infrequent and mainly limited to minor skin-related complications.' However, without comparative data against standard temporary abdominal closure techniques (e.g., negative pressure wound therapy with dynamic fascial traction), the incremental clinical value remains unquantified. Adoption would require surgical training, device procurement pathways, and integration into existing open abdomen management protocols. In Australia, the Fasciotens® device would require TGA registration (ARTG listing as a Class IIa or higher medical device) before clinical use. No current ARTG listing or TGA evaluation of Fasciotens® is referenced in this review. The RACGP and relevant surgical colleges (RACS) have not issued specific guidelines on vertical fascial traction devices. PBS listing is not applicable as this is a surgical device rather than a pharmaceutical. Australian hospital procurement would require Health Technology Assessment (HTA) evaluation, potentially through the Medical Services Advisory Committee (MSAC) process, before public hospital funding. The economic analysis suggesting reduced ICU stay and operative time is relevant to the Australian healthcare cost context but requires validation in prospective comparative trials before informing procurement decisions. Adult patients requiring open abdomen management (e.g., damage control surgery, abdominal compartment syndrome, peritonitis) or those with complex ventral hernias where primary fascial closure is the surgical goal. Applicable across general surgery, trauma surgery, and critical care settings.

Abstract

PURPOSE: Management of open abdomen (OA) and complex ventral hernias remains associated with high morbidity, prolonged hospitalization, and substantial healthcare costs. Vertical fascial traction has emerged as a novel approach aimed at facilitating early primary fascial closure. This study provides a narrative review and multidimensional overview of the available evidence regarding the Fasciotens® device, focusing on clinical outcomes, safety, economic considerations, and organizational aspects. METHODS: A narrative systematic literature review was performed to identify studies evaluating the use of Fasciotens® in adult patients with open abdomen or complex ventral hernias. Clinical, economic, organizational, and ethical domains were assessed. RESULTS: Available evidence, primarily derived from observational studies and case series, suggests that the use of Fasciotens® is associated with high rates of primary fascial closure, shorter time to closure, and reductions in intra‑abdominal pressure. Device‑related adverse events appear to be infrequent and mainly limited to minor skin‑related complications. Preliminary economic considerations indicate that earlier closure and avoidance of complex reconstructive procedures may reduce operative time, intensive care unit stay, and overall hospital resource utilization. CONCLUSION: Current evidence supports the clinical feasibility and potential value of Fasciotens® as an adjunctive technology for the management of open abdomen and complex ventral hernias. However, the available data are limited by small sample sizes and non‑comparative study designs. Further prospective and comparative studies are needed to better define its role within standardized treatment pathways.

References

1. 1.Rivano, M., Tatti, N., Filidoro, F., Cadeddu, A., Pisanu, A., & Podda, M. (2026). Fasciotens® for abdominal wall closure: current evidence and clinical perspectives. Hernia: The Journal of Hernias and Abdominal Wall Surgery. https://doi.org/10.3389/jaws.2025.14644