Efficacy and safety of applying oxidized regenerated cellulose sheets to the parietal pleura of open chest wounds in thoracic surgery: a prospective randomized controlled trial protocol.

BACKGROUND

According to a large-scale clinical trial in Japan, segmentectomy for small peripheral non-small cell lung cancer has an advantage over lobectomy in terms of overall survival, while it could also increase the incidence of local recurrence. In ipsilateral reoperations, intrathoracic adhesions from a previous surgery increase the risk of lung injury and bleeding, which may result in intraoperative and postoperative complications. The ability of oxidized regenerated cellulose (ORC) sheets to prevent postoperative adhesions has been demonstrated in the abdomen, and the same effect is expected in the thoracic region. The purpose of this study is to provide evidence supporting the application of ORC sheets to the parietal pleura of an open chest wounds to prevent postoperative adhesions in the thoracic region.

METHODS

This phase II prospective open-label, randomized, parallel-group study will validate adhesion prevention by applying ORC sheets to the parietal pleura of open chest wounds at the time of surgical closure. In the control group, the chest is closed by the usual procedure without ORC sheets. The primary endpoint is the presence rate of pleural adhesion findings on chest echography performed 4-20 weeks postoperatively. Data analysis will be performed in 2025-2026.

DISCUSSION

This study will provide evidence to the adhesion prevention effect of ORC sheet in the thoracic region, with the aim of establishing a strategy to prevent postoperative intrapleural adhesions.

TRIAL REGISTRATION

This trial has been registered on the Japan Registry of Clinical Trials 1032230271 (https://jrct.niph.go.jp/latest-detail/jRCT1032230271).