Comparative postoperative outcomes of autologous fibrin sealant pleurodesis versus talc pleurodesis in patients with spontaneous pneumothorax: a prospective cohort study

Introduction

Primary spontaneous pneumothorax (PSP) is a relatively common condition, with an annual incidence ranging from 7.4 to 18 cases per 100,000 males and 1.2 to 6 cases per 100,000 females (1-3). Recurrence rates are high, affecting 25% to over 50% of patients, often within the first year after the initial episode (4,5). Secondary spontaneous pneumothorax (SSP), though less frequent, is associated with pre-existing lung diseases such as emphysema and presents greater risks, particularly in medically vulnerable populations (1). Given the high recurrence rates and clinical impact of both PSP and SSP, effective treatment strategies are essential to ensure lung stability and prevent recurrent episodes.

Pleurodesis is a widely used technique for recurrent pneumothorax, aiming to create pleural adhesions and prevent further occurrences. Video-assisted thoracoscopic surgery (VATS) has become the gold standard for surgical management, allowing both air leak repair and pleurodesis. While different pleurodesis techniques, including pleurectomy, pleural abrasion, and talc poudrage, are commonly used, there is no consensus on the optimal method, with recurrence rates after surgical treatment varying from 0% to 19.2% (6-10).

For decades, both mechanical and chemical agents have been employed for pleurodesis, with talc being the most widely used sclerosing agent. However, concerns about its potential complications—such as restrictive lung disease, pulmonary toxicity, and the risk of acute respiratory distress syndrome (ARDS)—have led to the exploration of alternative agents. Autologous fibrin sealants have emerged as a potential alternative, offering similar efficacy while potentially reducing inflammatory complications (7,11-15). Unlike traditional fibrin glue derived from heterologous sources, autologous fibrin sealants eliminate the risk of viral transmission and have shown promising results in both animal and human studies for preventing air leaks and inducing pleural adhesions (16-21). Several reports have documented successful fibrin sealant pleurodesis in both pediatric and experimental settings, including preterm infants with persistent pneumothorax, with favorable safety profiles (16,17,22-29). Unlike talc poudrage, which induces pleurodesis through a foreign-body inflammatory reaction, autologous fibrin sealant promotes pleural adhesion by forming a biological fibrin scaffold that supports tissue apposition and healing. This mechanism may allow effective pleurodesis with a potentially lower inflammatory response. While talc pleurodesis remains widely used, direct comparative data with autologous fibrin sealant in spontaneous pneumothorax are limited.

At Ospedale Maggiore della Carità, Novara, pleurodesis strategies evolved over time according to surgeon experience and institutional availability. While talc poudrage remained the standard approach for several surgeons, autologous fibrin sealant was progressively adopted by others following its introduction, allowing a pragmatic comparison of two established pleurodesis techniques.

The objective of this study was therefore to compare postoperative outcomes—including pain, complications, and recurrence—between thoracoscopic talc poudrage and autologous fibrin sealant pleurodesis in patients with spontaneous pneumothorax. We present this article in accordance with the STROBE reporting checklist (available at https://ccts.amegroups.com/article/view/10.21037/ccts-2025-1-56/rc).

Methods

This study was designed as a prospective, single-center observational cohort study, aimed to compare outcomes of thoracoscopic pleurodesis using autologous fibrin sealant versus talc poudrage in patients with spontaneous pneumothorax. Treatment allocation was not based on patient-specific clinical characteristics but reflected stable practice patterns of individual surgeons. Specifically, some surgeons consistently performed talc poudrage, whereas others routinely adopted autologous fibrin sealant following its introduction at our institution, independent of patient profile.

The study included patients who underwent VATS at our institution between January 2020 and March 2023. Eligible patients were ≥14 years old. Written informed consent for surgery and data collection was obtained from all patients, or from their parents or legal guardians. Surgical indications included recurrent or bilateral pneumothorax, or a persistent air leak despite 5–7 days of chest drainage. Exclusion criteria were pregnancy, active infections, malignancy-related pneumothorax, or prior thoracic surgery. Of 69 surgically treated patients, 64 met these criteria, while three were excluded for malignancy-related pneumothorax, and two for a history of prior thoracic surgery. Patients with secondary pneumothorax often had underlying conditions like emphysema.

All surgeries followed standard care protocols. Preoperative data were collected from medical records, including demographics, medical history, type of pneumothorax, recurrence history, and smoking history. The Charlson Comorbidity Index was used to assess comorbidity burden.

Procedures and postoperative care reflected our hospital’s standard practice. All procedures were performed via VATS. Bullectomy or blebectomy was done with an endoscopic stapler, followed by pleurodesis. In both groups, the aim was to achieve homogeneous pleural coverage under thoracoscopic visualization, following standardized institutional protocols. In the talc group, 4 grams of sterile talc were uniformly insufflated under thoracoscopic visualization. In the talc pleurodesis group, sterile asbestos-free talc was insufflated under thoracoscopic guidance using a simple manual delivery system. Talc was loaded into a 50-mL large-volume catheter-tip syringe, connected to a 14 Ch suction catheter. The catheter was introduced into the thoracic cavity and talc was gently insufflated by manual piston advancement under direct endoscopic visualization, which helped achieve uniform and controlled dispersion of the sterile talc powder over both the visceral and parietal pleural surfaces.

In the fibrin pleurodesis group, 120 mL of autologous peripheral blood was collected intraoperatively and processed using the Vivostat^® system (Vivostat A/S, Allerød, Denmark) to generate an autologous fibrin sealant. This system produces a fibrin-rich, cell-free matrix through automated processing of the patient’s blood, resulting in a viscous biological sealant suitable for endoscopic application. The generated autologous fibrin sealant was then evenly sprayed over the lung surface using a dedicated endoscopic applicator. This technique differs fundamentally from conventional autologous blood pleurodesis, which involves the direct intrapleural instillation of whole blood without processing. In contrast, the Vivostat^® system generates a standardized autologous fibrin sealant, allowing controlled application and a more uniform fibrin matrix. A chest tube was placed intraoperatively, connected to a water seal without suction, and removed after at least 12 hours without leaks. Routine chest X-rays were taken, and pain was managed with intravenous paracetamol (1 g every 8 hours) and ketorolac (30 mg twice daily for breakthrough pain), or tramadol (50 mg twice daily) for nonsteroidal anti-inflammatory drug (NSAID)-allergic patients. Early mobilization, respiratory exercises, and physical rehabilitation were encouraged to support recovery.

The outcomes evaluated were chest drain duration, postoperative pain, complications, and recurrence rates. Postoperative pain was assessed using a Numeric Rating Scale (NRS) as part of routine postoperative care. Given the nature of the surgical interventions, neither patients nor clinicians were blinded to the pleurodesis technique. Long-term outcomes were monitored through follow-up chest X-rays for a minimum of 24 months. Data were collected using the REDCap system.

Statistical analysis

Baseline descriptive statistics were calculated for each variable by treatment group, with continuous variables summarized as means and standard deviations or medians and interquartile ranges, and categorical variables presented as frequencies and percentages. Statistical tests, including t-tests, Chi-squared tests, and Wilcoxon rank-sum tests, were performed as appropriate to compare the groups. Based on the observational nature of the study, the propensity score was computed using a covariate balancing propensity score (CBPS) (30) model which included age, sex, type of pneumothorax (primary or secondary), and surgical indication. Weighting based on these propensity scores was applied in subsequent analyses to ensure the balance between treatment arms. For continuous outcomes (e.g., chest drain duration), generalized linear models (GLMs) with gamma family distributions were employed, incorporating propensity score weights. Marginal effects for these models were estimated and reported.

Binary outcomes, such as abnormal chest X-rays at discharge, were analyzed using logistic regression models with propensity score weights. Odds ratios with 95% confidence intervals (CIs) were reported. For time-to-event data, recurrence-free survival was analyzed between randomization arms using propensity-weighted Cox proportional hazards models. Adjusted hazard ratios (HRs) with corresponding CIs were derived. Follow-up was complete for all included patients. No patients were lost to follow-up, and no imputation for missing data was required. All statistical tests were two-sided, and a P value <0.05 was considered statistically significant.

A longitudinal analysis using a generalized additive model for location, scale, and shape (GAMLSS) was performed to assess the association between treatment arm and postoperative NRS pain scores over four time points. The model included treatment arm and time as fixed effects and patient ID as a random intercept to account for intra-individual correlation across repeated measures. As observed postoperative NRS scores ranged from 0 to 4, a truncated normal distribution (0–4) was applied to reflect the empirical data distribution and avoid boundary violations. Analyses were weighted using pre-computed propensity score weights to mitigate potential confounding between treatment groups. All analyses were weighted to account for the covariate balancing achieved through the CBPS (30) methodology. All analyses were conducted using R version 4.2.2 (31).

Ethical consideration

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments and was approved by the institutional ethics committee of AOU Maggiore della Carità di Novara (No. CE 76/20). Written informed consent was obtained from all patients, or from their parents or legal guardians.

Results

The study included 30 patients in the talc pleurodesis group and 34 patients in the autologous fibrin pleurodesis group. Patient inclusion and exclusion are detailed in the study flow diagram (Figure 1). Baseline demographic and clinical characteristics were largely comparable between the two groups. The fibrin group had a significantly greater mean height (P=0.02) and a higher proportion of current smokers (P=0.03). The distribution of primary and secondary pneumothorax, the frequency of prior pneumothorax episodes, surgical indications, and lung resection rates were similar across groups. A summary of baseline characteristics is provided in Table 1. These variables were accounted for in the propensity score model to mitigate potential confounding. The operative time was significantly shorter for the talc group (median 40 vs. 45 minutes, P=0.047). Regarding postoperative pain, initial NRS scores were similar on postoperative day 1 (P=0.06). However, from day 2 onward, patients in the talc group consistently reported significantly higher pain scores compared to the fibrin group (P<0.001).

Figure 1 Flow diagram illustrating patient selection, exclusion, treatment allocation, and inclusion in the final analysis.

The chest drain duration was also slightly longer in the talc group (P=0.048), although hospital stay and air leak duration were similar between the two. The length of stay in the hospital was 4.5 days (range, 4–7 days) in the talc group and 4 days (range, 3–7 days) in the fibrin group (P=0.38), while the air leak duration was 2 days (range, 1–4 days) in the talc group and 1 day (range, 0.25–3 days) in the fibrin group (P=0.1) (Table 2).

Postoperative complications were comparable, occurring in 20% of talc patients and 21% of fibrin patients, with no significant difference in overall complication rates (P=0.95). All reported complications were minor, and there was no significant difference in the incidence of prolonged air leaks lasting more than five days occurring in 20% of patients in the talc group and 15% in the fibrin group (P=0.57). Similarly, follow-up findings from chest X-rays and pain scores at two weeks and one month were comparable between the groups.

Follow-up was completed for all included patients, with a median duration of 36.5 months in both groups. During this period, one patient in the talc group experienced a pneumothorax recurrence 11 months after surgery, while no recurrences were observed in the fibrin group. While this difference was not statistically significant in the unadjusted analysis (P=0.28), after propensity score adjustment, fibrin pleurodesis was associated with a significantly lower recurrence risk (adjusted HR: 0.25; 95% CI: 0.07–0.94; P=0.04), suggesting a potential reduction in recurrence risk (Table 3).

Notably, some variables that showed statistical significance in the unadjusted analysis lost significance after adjustment. The chest drain duration, which was initially significantly shorter in the fibrin pleurodesis group (P=0.048), did not retain statistical significance after adjustment, with an adjusted average marginal effect (AME) of −1.04 days (95% CI: −3.22 to 1.14, P=0.35). Similarly, air leak duration was not significantly different between groups after adjustment (AME: −1.07 days, 95% CI: −3.31 to 1.18, P=0.35). The operative time, despite the initial difference observed (P=0.047), was no longer significantly different after adjustment (AME: 0.78 minutes, 95% CI: −6.12 to 7.68, P=0.82).

The main effect of fibrin treatment is significant on the NRS scale suggesting that fibrin treatment is effective in improving pain management (Table 4). A time-dependent reduction in pain scores is observed.

Discussion

This study evaluated the efficacy of thoracoscopic pleurodesis using autologous fibrin sealant compared with talc poudrage in patients with spontaneous pneumothorax.

Air leak durations and hospital stay were similar between treatment groups. Complications were minimal, and most patients experienced none. After adjustment for confounders, no significant differences were observed in chest drain duration or air leak resolution, indicating comparable efficacy of the two techniques. Overall recurrence rates were low (3% in the talc group and 0% in the fibrin group), although the adjusted analysis suggested a signal toward a lower recurrence risk with fibrin pleurodesis.

Overall, the findings suggest the autologous fibrin group had lower pain levels, while both treatment options demonstrated comparable efficacy in preventing recurrence and offering similar outcomes in terms of complications and long-term follow-up. Differences in postoperative pain and operative time were observed.

Operative time was slightly shorter in the talc pleurodesis group (40 vs. 45 minutes, P=0.047). The modest increase with fibrin pleurodesis may reflect the additional steps required for sealant preparation and application (32-35). After propensity score adjustment, this difference was no longer statistically significant, suggesting that it may have been influenced by confounding factors rather than representing an inherent limitation of fibrin pleurodesis.

Postoperative pain represented a key differentiating outcome. On the first postoperative day, pain scores were comparable between groups. From postoperative day 2 onward, patients in the talc group consistently reported higher NRS scores (Table 4).

This difference is plausibly related to the inflammatory reaction induced by talc, whereas autologous fibrin sealant may elicit a milder inflammatory response. These findings are consistent with previous studies reporting increased post-procedural pain after talc pleurodesis (12,36,37). Although the observed reductions in pain and operative time were modest, they may still be clinically meaningful in the context of minimally invasive surgery, particularly when aiming to reduce early postoperative discomfort.

Although the fibrin group included patients with secondary pneumothorax and second episodes, the effectiveness of fibrin pleurodesis was not compromised. Parameters like hospital stay and air leak duration did not show significant differences between the groups, which is consistent with other studies on fibrin sealant, that report good outcomes in terms of hospital stay and air leak resolution (32,35,38-44).

We observed a low recurrence rate in both the talc and fibrin sealant groups during follow-up. One patient in the talc group experienced a recurrence, while no recurrences were observed in the fibrin sealant group. While this unadjusted difference was not statistically significant, the propensity score-adjusted analysis suggested a lower risk of recurrence with fibrin sealant, with an adjusted HR of 0.25 (95% CI: 0.07–0.94, P=0.04). This finding should be considered exploratory. Our results are consistent with the literature, which reports a recurrence rate of pneumothorax after talc pleurodesis ranging from 1.1% to 10.8%, with most events occurring within the high-risk period of 2 years post-surgery (45). The follow-up duration was comparable between the two groups, which strengthens the validity of the comparison by reducing the likelihood of time-related bias influencing the recurrence rates.

To the best of our knowledge, this is the first study to investigate the use of autologous fibrin sealant for pleurodesis in spontaneous pneumothorax. Unlike talc, which uses a foreign-body inflammatory reaction, autologous fibrin sealant represents a novel, biologically natural approach. This leverages the body’s own coagulation mechanisms to promote pleural adhesion with potentially reduced inflammation and improved postoperative tolerance.

This study has several limitations that should be acknowledged. First, its observational and non-randomized design introduces the potential for selection bias. Treatment allocation was based on surgeon-specific practice patterns rather than patient-level clinical characteristics, which reduces the risk of confounding by indication; however, residual confounding—particularly related to unmeasured surgeon-level factors, surgical technique, or perioperative management—cannot be fully excluded. Second, the relatively small sample size limits statistical power, especially for infrequent outcomes such as pneumothorax recurrence. The study was not powered to detect differences in recurrence rates, and with only one recurrence event observed, recurrence analyses should therefore be interpreted with caution. Although the median follow-up of 36.5 months was adequate for assessing short- to mid-term outcomes, it may not capture subtle long-term differences or rare complications. Third, the absence of blinding in postoperative pain assessment may have introduced reporting bias. Finally, as a single-center study, these findings may reflect institutional practices and surgeon experience, potentially limiting generalizability to other settings. Taken together, these limitations indicate that the present findings should be interpreted as exploratory and hypothesis-generating.

While the unadjusted analysis suggested similar recurrence rates, the adjusted analysis highlights a potential benefit of fibrin pleurodesis in reducing recurrence risk. This finding, along with the trend toward lower postoperative pain, suggests that fibrin pleurodesis could be a promising alternative to talc, particularly for patients prioritizing a less painful recovery. It should be acknowledged that talc pleurodesis is currently considered a safe and effective technique when appropriately used, and severe complications such as acute respiratory distress syndrome are rare in contemporary practice. Larger-scale studies with extended follow-up are necessary to confirm these findings and better define the role of fibrin pleurodesis in clinical practice. Future research should also explore the molecular mechanisms underlying differences in inflammatory responses and pain outcomes.

Conclusions

This study is the first to directly compare talc pleurodesis with autologous fibrin pleurodesis. The results suggest that both techniques are similarly effective in resolving postoperative air leaks and achieving pleurodesis. Notably, adjusted analyses revealed a lower recurrence risk and lower postoperative pain in the fibrin pleurodesis group, supporting the hypothesis that this technique induces less pleural inflammation. Operative time was not significantly different after adjustment, indicating that both procedures are comparable in terms of technical feasibility. The findings suggest that autologous fibrin pleurodesis could be a promising alternative to talc poudrage. Larger randomized controlled trials with extended follow-up are necessary to confirm these results and define the role of fibrin pleurodesis in clinical practice.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://ccts.amegroups.com/article/view/10.21037/ccts-2025-1-56/rc

Data Sharing Statement: Available at https://ccts.amegroups.com/article/view/10.21037/ccts-2025-1-56/dss

Peer Review File: Available at https://ccts.amegroups.com/article/view/10.21037/ccts-2025-1-56/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://ccts.amegroups.com/article/view/10.21037/ccts-2025-1-56/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments and was approved by the institutional ethics committee of AOU Maggiore della Carità di Novara (No. CE 76/20). Written informed consent was obtained from all patients, or from their parents or legal guardians.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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