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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

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

Suzuki Hidemi

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan

h-suzuki@chiba-u.jp

Ochi Takahiro

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan

+81-43-222-7171

cdaa6659@chiba-u.jp

Recruiting

Aug. 01, 2023

Interventional

randomized controlled trial

single blind

no treatment control/standard of care control

parallel assignment

prevention purpose

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.

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.

Both

Pulmonary disease requiring surgery with incision of the parietal pleura.

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.

pulmonary diseases

adhesion barrier, ipsilateral repeat lung resection, oxidized regenerated cellulose sheet

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

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)

+81-43-226-2616

July. 18, 2023

No

none