RESUMEN
Novel interventions for seroma prevention are urgently needed in clinical practice. Animal models are pivotal tools for testing these interventions; however, a significant translational gap persists between clinical and animal model outcomes. This systematic review aims to assess the methodological characteristics and quality of animal models utilized for seroma prevention. A meta-analysis was performed to estimate the expected seroma incidence rate for control groups and determine the effect size of typical interventions. We systematically retrieved all studies describing animal models in which seroma formation was induced. Methodological characteristics, risks of bias, and study quality were assessed. Seroma volume and -incidence data were used for the meta-analysis. In total, 55 studies were included, with 42 eligible for meta-analysis. Rats (69%) were the most frequently used species, with mastectomy (50%) being the predominant surgical procedure in these models. Despite significant risks of bias across all studies, an improving trend in reporting quality per decade was observed. The meta-analysis revealed an average seroma incidence of 90% in typical control groups. The average intervention halved the seroma incidence (RR = 0.49; CI 0.35, 0.70) and significantly reduced seroma volume (SMD = -3.31; CI -4.21, -2.41), although notable heterogeneity was present. In conclusion, animal models for seroma prevention exhibit methodological flaws and multiple risks of bias. Implementing sufficiently powered positive and negative control groups could improve the internal validity of these models. More research is needed for further development of animal seroma models.
RESUMEN
Sealants may provide a solution for pulmonary air leakage (PAL), but their clinical application is debatable. For sealant comparison, standardized animal models are lacking. This systematic review aims to assess methodology and quality of animal models for PAL and sealant evaluation. All animal models investigating lung sealing devices (e.g., staplers, glues, energy devices) to prevent or treat PAL were retrieved systematically from Embase, Pubmed and Web of science. Methodological study characteristics, risk of bias, reporting quality and publication bias were assessed. A total of 71 studies were included (N = 75 experiments, N = 1659 animals). Six different species and 18 strains were described; 92% of experiments used healthy animals, disease models were used in only six studies. Lesions to produce PAL were heterogenous, and only 11 studies used a previously reported technique, encompassing N = 5 unique lesions. Clinically relevant outcomes were used in the minority of studies (imaging 16%, air leak 10.7%, air leak duration 4%). Reporting quality was poor, but revealed an upward trend per decade. Overall, high risk of bias was present, and only 18.7% used a negative control group. All but one study without control groups claimed positive outcomes (95.8%), in contrast to 84.3% using positive or negative control groups, which also concluded equivocal, adverse or inconclusive outcomes. In conclusion, animal studies evaluating sealants for prevention of PAL are heterogenous and of poor reporting quality. Using negative control groups, disease models and quantifiable outcomes seem important to increase validity and relevance. Further research is needed to reach consensus for model development and standardization.