Clarifications on a prospective randomized controlled trial evaluating adhesion prevention using oxidized regenerated cellulose sheets in thoracic surgery

We sincerely appreciate Dr. Franceschini (1) for insightful comments and valuable feedback on our study protocol for the application of oxidized regenerated cellulose (ORC) sheets to the parietal pleura of open chest wounds in thoracic surgery (2). Our study aims to evaluate the efficacy and safety of ORC sheet application to the pleura in preventing adhesion formation between the lung and chest wall following thoracic surgery. To achieve this, patients are randomly assigned to the ORC-applied group or non-applied group, and the presence of adhesions is evaluated using chest echography by a technologist blinded to group allocation. The protocol includes a comprehensive evaluation of the safety of ORC sheet application. Furthermore, we have established eligibility criteria, enrolling only patients with preserved organ functions to minimize the unintended effect on ORC sheet absorption and application risk.

We acknowledge the potential risks highlighted by Dr. Franceschini, including incomplete ORC absorption, which could lead to complications such as foreign-body reactions, inflammation, fibrosis, and misdiagnosis of tumor recurrence or abscess. Nevertheless, according to the manufacturer’s instructions, ORC sheet forms a gel-like membrane after application which can block the spread of fibrin and prevent adhesion formation, and is completely absorbed within approximately 4 weeks. Since the thoracic cavity has a circulatory system of body cavity fluid, as in the abdomen, the environment is likely to be favorable for sheet absorption, making it unlikely for ORC sheets to remain in the thoracic cavity. A previous report confirmed that during reoperation on the ipsilateral thoracic cavity, the ORC sheets applied to the lung surface were completely absorbed more than one month after the initial procedure (3). In our experience, the presence of ORC sheets could be identified by postoperative X-ray imaging as a decreased radiolucency immediately after surgery, but it completely disappeared within a few weeks. Moreover, the risk of misdiagnosis in image interpretation is concerning particularly in areas with complex anatomy, such as the hilum. In contrast, the target area of our study is a relatively simple anatomical region located beneath the chest wall; thus, the difficulty of image evaluation could be lower compared to that of complex areas. As outlined above, a detailed evaluation by a specialist radiologist is not considered necessary. We ensure that ORC sheets are cut appropriately and applied in precise amounts to avoid overuse. Additionally, we carefully monitor delayed wound healing after surgery and manage the risk of chest infection by administering antibiotics while the drains remain in place.

Our study is designed to comprehensively evaluate the efficacy and safety of ORC sheet application in clinical practice. Patients will be carefully monitored throughout the study period, and data will be collected and analyzed to address the concerns raised. Based on our findings, we anticipate that larger follow-up studies will be conducted to further assess the long-term clinical impact of ORC sheets in thoracic surgery.

Once again, we express our gratitude to Dr. Franceschini for the thoughtful feedback, which has allowed us to delve deeper into the potential of ORC sheets and refine key aspects of our research.

Acknowledgments

None.

Footnote

Provenance and Peer Review: This article was commissioned by the editorial office, Journal of Thoracic Disease. The article did not undergo external peer review.

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-160/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

References

1. Franceschini G. Oxidized regenerated cellulose in thoracic surgery: potential game-changer or hidden danger? J Thorac Dis 2025;17:2749-51. [Crossref]
2. Ochi T, Suzuki H, Sata Y, et al. 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. J Thorac Dis 2024;16:8149-55. [Crossref] [PubMed]
3. Hokka D, Tanaka Y, Shimizu N, et al. Oxidized Regenerated Cellulose Sheets in Postoperative Intrathoracic Adhesions. Ann Thorac Cardiovasc Surg 2022;28:32-5. [Crossref] [PubMed]