Abstract
Objective
The aim of this study was to identify resorption, clinical performance, and safety of cotton-derived oxidized cellulose gauze applied as a hemostat in minimally invasive oncologic thoracic surgery.
Methods
This is a pilot prospective noncomparative observational human in vivo study. A piece of cotton-derived oxidized cellulose gauze measuring 5 × 20 cm was inserted into the subcarinal space of patients with potentially resectable lung carcinoma at the time of video-assisted mediastinoscopic lymphadenectomy and reexamined several days later for macroscopic and histologic evaluation at the time of subsequent lung resection. The primary endpoint was the local situation at the implantation site described by cellulose remnants, fluid collections, and adhesions. The secondary endpoint was safety, described by the number of adverse events and surgical reinterventions.
Results
Twenty-five consecutive eligible patients with potentially resectable lung carcinoma were included. The desired hemostatic effect was achieved in all cases. No adverse events were observed. At re-exploration 10.5 (5–28) days later, the cellulose gauze was found to lose its solid structure from the fifth day on. Remnants were last detected 14 days after insertion. The implantation site exhibited no inflammatory changes and a remarkable small amount of fluid collections and adhesions.
Conclusions
Mediastinal application of cotton-derived oxidized cellulose is safe and effective. A piece of gauze measuring 5 × 20 cm seems to be absorbed completely within 15 days, thus precluding any interference with oncologic restaging and follow-up. The absence of relevant adhesions facilitates further surgical procedures. Larger comparative confirmatory studies are required. For large-scale resorption studies, our clinical model should be translated into a porcine model.
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