Feasibility of application of an absorbable topical collagen hemostat sheet (INTEGRAN(®)) for prevention of postoperative recurrence of pneumothorax in youths

BACKGROUND: Staple-line coverage is an effective method for prevention of postoperative recurrence of pneumothorax. However, the recurrence rate in young patients is still unsatisfactory using this method. Moreover, there is no consensus about the optimal material for use in this technique. To explore new material for this technique, we conducted this study to evaluate the safety of an absorbable topical collagen hemostat (INTEGRAN(®)) for staple-line coverage in pneumothorax surgery in young patients. METHODS: A single-arm prospective interventional study was performed in 25 patients (age <25 years old) with primary spontaneous pneumothorax (PSP) who underwent wedge resection with staple-line coverage with INTEGRAN(®) between 2017 and 2020. The rate of material-related adverse events (defined as a body temperature ≥38 ℃ continuing for ≥2 days, postoperative WBC >18,000/mm(3) and/or CRP >15 mg/dL, or acute empyema within 30 postoperative days) was defined as the primary endpoint. The 1-year postoperative rates of recurrence and of new bullae around the staple-line were also measured. RESULTS: The median age was 19 years old. None of the patients had a body temperature ≥38 ℃ continuing for ≥2 days, extra-abnormal examination data, and acute empyema findings. At 1-year postoperatively, the recurrence rate was 12.0%, and the rate of new bullae around the staple-line was 16.7%. CONCLUSIONS: 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. TRIAL REGISTRATION: UMIN000026530 at UMIN Clinical Trials Registry