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Randomized Controlled Trial to Evaluate the Prevention of Postoperative Adhesions by Applying Regenerated Oxidized Cellulose Sheets in Thoracic Surgery

A Single-Center Prospective Randomized Controlled Trial to Evaluate the Prevention of Postoperative Adhesions by Applying Regenerated Oxidized Cellulose Sheets to the Parietal Pleura of Open Chest Wound in Thoracic Surgery

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032230271
Enrollment
240
Registered
2023-08-01
Start date
2023-09-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary disease requiring surgery with incision of the parietal pleura. pulmonary diseases

Interventions

For the group using oxidezed regenerated cellulose sheets, the sheets will be applied to the parietal pleura of open chest wall at the end of surgery.
adhesion barrier, ipsilateral repeat lung resection, oxidized regenerated cellulose sheet

Sponsors

Suzuki Hidemi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following conditions are eligible. 1) Adults 18 years of age or older at the time of consent. 2) ECOG performance status (PS) of 0-2. 3) Main organ function is preserved. 4) Patients undergoing initial surgery to the affected chest or thoracic cavity. 5) Patients who have been fully informed of the study and have given their informed and voluntary written consent to participate in the study.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following conditions are not eligible. 1) Patients with a history of intraoperative thoracic drainage. 2) Patients with a history of inflammatory diseases including pneumonia on the surgical side. 3) Patients who may undergo a total lung resection or a combined chest wall resection at surgery. 4) Patients with dementia or other conditions that require surrogate consent. 5) Patients who are pregnant, possibly pregnant, within 28 days postpartum, or lactating. 6) Other patients who are judged by the principal investigator or subinvestigator to be inappropriate for the safe conduct of this study.

Design outcomes

Primary

MeasureTime frame
Presence of pleural adhesion findings on chest echography performed 4-12 weeks postoperatively

Secondary

MeasureTime frame
1) Postoperative wound infection 2) Postoperative aerial fistula 3) Prolonged aerial fistula 4) Delayed aerial fistula 5) Postoperative bleeding 6) Postoperative period of chest drain placement (days)

Contacts

Public ContactTakahiro Ochi

Chiba University Hospital

cdaa6659@chiba-u.jp+81-43-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026