Key result
Collagen membrane fails to reduce pericardial adhesions vs. no repair in preclinical trial.
Why the study?
Resternotomy in open-heart surgery is complicated by pericardial adhesions, and collagen membranes have shown potential in adhesion prevention in other body regions.
Does a collagen membrane prevent pericardial adhesions in a porcine model of open-heart surgery?
RCT (n=12)
Single-blind
Randomly divided
Does a collagen membrane prevent pericardial adhesions in a porcine model of open-heart surgery?
p-value: p=>.05
The use of a collagen membrane did not significantly reduce macroscopic or microscopic pericardial adhesions in a porcine model of open-heart surgery.
Non-significant adhesion reduction with collagen membrane in pigs; leaves open efficacy of alternative materials before clinical translation.
OBJECTIVE: The operating procedure of a resternotomy in open-heart surgery is a complicated procedure with potentially problematic outcomes partly due to potential adhesions in the pericardial cavity and retrosternal space. Use of a collagen membrane has shown encouraging results in adhesion prevention in several regions of the body. This study was designed to evaluate the effectiveness of the use of this collagen membrane in the prevention of pericardial adhesions. MATERIALS AND METHODS: A total of 12 pigs were divided randomly into 2 groups: an experimental group in which collagen membranes were used and a control group. After sternotomy and an anterior pericardiectomy, the epicardial surface was exposed to room air and irrigated with saline, and an epicardial abrasion was performed using a sponge. The pericardial defect was repaired using a collagen membrane in the experimental group or left uncovered in the control group. After 8 to 12 weeks, the pigs were killed, and a resternotomy was performed by a single-blinded surgeon enabling the evaluation of adhesions. The heart was then removed and sent for microscopic assessment conducted by a single-blinded pathologist. RESULTS: > .05), particularly in the retrosternal and defect regions. CONCLUSIONS: This study showed nonstatistically significant differences between the outcomes in the collagen membrane group and the control group in both macroscopic and microscopic adhesion prevention. Due to the many limitations in animal study design, further studies in human models will be needed before the true value of this procedure can be evaluated.
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Taksaudom et al. (2017) conducted an RCT in Postoperative pericardial adhesions (n=12). Collagen membrane vs. Left uncovered was evaluated on Macroscopic and microscopic adhesion prevention (p=>.05). Use of a collagen membrane for pericardial defect repair in pigs showed nonstatistically significant differences in macroscopic and microscopic adhesion prevention compared to control (P > .05).
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