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A Prospective Study Investigating Fistula Rate Following Primary Palatoplasty Using Acellular Dermal Matrix.

ABSTRACT: 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.

SUBMITTER: Gilardino MS

PROVIDER: S-EPMC6157948 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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A Prospective Study Investigating Fistula Rate Following Primary Palatoplasty Using Acellular Dermal Matrix.

Gilardino Mirko S MS Aldekhayel Salah S Govshievich Alexander A

Plastic and reconstructive surgery. Global open 20180615 6

<h4>Background</h4>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.<h4>Methods</h4>A prospective clinical tria ...[more]

PMID: 30276053

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Project description:Regeneration of periodontal tissue is the most promising method for restoring periodontal structures. To find a suitable bioactive three-dimensional scaffold promoting cell proliferation and differentiation is critical in periodontal tissue engineering. The objective of this study was to evaluate the biocompatibility of a novel porcine acellular dermal matrix as periodontal tissue scaffolds both in vitro and in vivo. The scaffolds in this study were purified porcine acellular dermal matrix (PADM) and hydroxyapatite-treated PADM (HA-PADM). The biodegradation patterns of the scaffolds were evaluated in vitro. The biocompatibility of the scaffolds in vivo was assessed by implanting them into the sacrospinal muscle of 20 New Zealand white rabbits. The hPDL cells were cultured with PADM or HA-PADM scaffolds for 3, 7, 14, 21 and 28 days. Cell viability assay, scanning electron microscopy (SEM), hematoxylin and eosin (H&E) staining, immunohistochemistry and confocal microscopy were used to evaluate the biocompatibility of the scaffolds. In vitro, both PADM and HA-PADM scaffolds displayed appropriate biodegradation pattern, and also, demonstrated favorable tissue compatibility without tissue necrosis, fibrosis and other abnormal response. The absorbance readings of the WST-1 assay were increased with the time course, suggesting the cell proliferation in the scaffolds. The hPDL cells attaching, spreading and morphology on the surface of the scaffold were visualized by SEM, H&E staining, immnuohistochemistry and confocal microscopy, demonstrated that hPDL cells were able to grow into the HA-PADM scaffolds and the amount of cells were growing up in the course of time. This study proved that HA-PADM scaffold had good biocompatibility in animals in vivo and appropriate biodegrading characteristics in vitro. The hPDL cells were able to proliferate and migrate into the scaffold. These observations may suggest that HA-PADM scaffold is a potential cell carrier for periodontal tissue regeneration.

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A Prospective Study Investigating Fistula Rate Following Primary Palatoplasty Using Acellular Dermal Matrix.

Publications

A Prospective Study Investigating Fistula Rate Following Primary Palatoplasty Using Acellular Dermal Matrix.

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