Feasible study on use of sheet-type absorbable topical collagen hemostat (press-sheet type Integran(R)) for prevention of postoperative recurrence of pneumothorax in young patients.
- Conditions
- spontaneous pneumothorax
- Registration Number
- JPRN-UMIN000026530
- Lead Sponsor
- Kanto Rosai Hospital
- Brief Summary
This study showed the safety of use of INTEGRAN for staple-line coverage in pneumothorax surgery in young adults. The short-term recurrence rate was acceptable given the high-risk cohort examined in the study. A prospective randomized controlled study is needed for evaluation of the efficacy of INTEGRAN for prevention of recurrence of PSP.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Not provided
(1)Secondary spontaneous pneumothorax patients (2)Synchronous bilateral pneumothorax patients (3)Patients with shock vital sign (Systolic blood pressure <80 mmHg and HR > 100 bpm) or with hemothorax more than 1,000 ml (4)With medical history of ipsilateral thoracic surgery. (5)Patients with hypersensitivity to bovine derived products (insulin, glucagon etc.) (6)Patients with pregnancy (7)Patients who are assessed by investigator as "inadequate for enrollment" .
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method