Background: Acellular dermal matrix (ADM) has been described as an adjunct in primary cleft palate repair to reduce the fistula rate in several retrospective studies (level III or lower); however, current data are insufficient to definitively conclude its efficacy for this purpose. The goal of the present study was to provide prospective, higher level of evidence data investigating the effect of ADM on fistula rate following primary palatoplasty.
Methods: A prospective clinical trial was conducted in which ADM was used uniformly in all primary cleft palate repairs that met inclusion criteria. For comparison, a matched control group was identified (retrospectively) from the same center/surgeon's database. Primary outcome was the rate of palatal fistula formation. Secondary outcomes included bleeding, infection, and delayed healing.
Results: A total of 130 patients were included in the analysis consisting of 65 in both the study and control groups. There were no statistically significant differences in patient demographics or cleft /surgical characteristics. The results demonstrated a fistula rate of 1.5% in the study group versus 12.3% in the control group (P = 0.03). The other complications (infection, bleeding, delayed healing) were similar between the groups.
Conclusion: The study provides the highest level of evidence currently available (level II, prospective data) investigating the effect of ADM on fistula rate following primary palatoplasty. The results demonstrate a low overall fistula rate (1.5%) and suggest there may be a clinically significant reduction in fistula formation associated with the routine use of ADM in all primary palate repairs.