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

JRCT ID: jRCT1032230271

Registered date:01/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pulmonary disease requiring surgery with incision of the parietal pleura.
• Date of first enrollment: 05/09/2023
• Target sample size: 240
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Presence of pleural adhesion findings on chest echography performed 4-12 weeks postoperatively

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Suzuki Hidemi
• Source(s) of Monetary Support: Clinical Reseach Initiation-Fund (of Chiba University Hospital)