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Ventral hernia repair is among the most commonly performed general surgical procedures, during which meshes are often used to provide further support to weakened or damaged tissue surrounding the hernia repair site. Slowly resorbable synthetic meshes have recently emerged as a valid choice, as confirmed by published clinical evidence on launched meshes in the repair of ventral hernias showing satisfactory results. This study was designed to assess the performance and safety of a newly developed slowly fully resorbable self-gripping synthetic mesh in patients undergoing ventral hernia repair through open surgery in clean and clean-contaminated fields.
This is a prospective, multicentre, single-arm study that will be conducted in up to 20 European and US sites with a total of 163 patients undergoing midline primary or incisional ventral hernia repair in clean or clean-contaminated surgical fields using an open surgical approach and implanted with Transorb self-gripping resorbable mesh in retrorectus placement with or without transversus abdominis release. The study will include patients ≥18 years old, presenting at least one risk factor impairing wound healing. The primary endpoint will be hernia recurrence rate within 12 months, postoperatively evaluated by physical exam; secondary endpoints will include hernia recurrence rate within 1 month, 6 months, 24 months, 36 months, 48 months and 60 months postoperatively, hernia recurrence rate resulting in reoperation, hernia recurrence rate reported by patients, time to hernia recurrence, rate of surgical site occurrence (SSO), rate of SSO requiring procedural interventions, surgeon satisfaction and change in patient-reported pain and quality of life. The study will be considered successful if the upper limit of the 95% Bayesian credible interval for the primary endpoint is less than 14.2%. Descriptive statistics will be used to summarise secondary study endpoints unless otherwise noted.
The multicentre, single-arm, prospective study of Transorb self-gripping resorbable mesh in subjects undergoing open repair of ventral hernia study will be conducted in compliance with the Good Clinical Practice standards, ISO 14155:2020 and the Declaration of Helsinki. The publication plan includes dissemination of the 12-month, 24-month, 36-month, 48-month and 60 month study results.
The RECOVER study has been registered at clinicaltrials.gov (NCT06449378).
by Alexandra Goldblatt, Michael J. Loccisano, Mazharul I. Mahe, John J. Dennehy, Fabrizio Spagnolo
The COVID-19 pandemic highlighted the role of indoor environments on disease transmission. However, our understanding of how transmission occurred evolved as the pandemic progressed. Enclosed spaces where pathogen-laden aerosols accumulate were strongly linked to increased transmission events. Most classrooms, particulalry in the U.S., do not have any mechanical ventilation systems but do have many people congregating indoors for long periods of time. Here we employ a safe, non-pathogenic surrogate virus, the bacteriophage phi6, to interrogate aerosol transmission in classroom environments that do not have any natural or mechanical ventilation in order to provide baseline understanding of how effectively aerosols facilitate new infections. We measure exposure risk using a modified passive monitoring technique compliant with applicable standards, including ISO 14698–1:2003. We find that virus-laden aerosols establish new infections over all distances tested within minutes and that the time of exposure did not change transmission rate. We further find that relative humidity, but not temperature nor a UV-based disinfection device, significantly lowered transmission rates. Our data suggest that, even without mechanical ventilation, relative humidity remains an inexpensive and highly effective mitigation strategy while UV air treatment may not.
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