N/A
N=131
Acellular Dermal Matrix in Primary Palatoplasty
Cleft Palate
Bottom Line
View on ClinicalTrials.gov: NCT01867632 ↗Enrolled (actual)
131
Serious AEs
—
Results posted
Jun 2017
Primary outcome: Primary: Fistula Formation — 1; 8 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Acellular Dermal Matrix (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Mirko S. Gilardino
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fistula Formation |
1; 8 | — |
| SECONDARY Number of Participants With Wound Infection |
0; 0 | — |
Summary
The goal of the present study is to definitely determine whether the use of acellular dermal matrix (ADM) during primary cleft palate repair decreases the rate of fistula formation. Although individual studies have described promising advantages to its use in cleft palate surgery, no consensus currently exists. Without concrete evidence, one must question the whether the increased cost, time and potential patient risk (human derived tissue) to patients justifies its use in primary cleft palate repair.
Eligibility Criteria
Inclusion Criteria
- Children diagnosed as having Veau class II to IV cleft palates undergoing Furlow palatoplasty with ADM between the ages of 3 months and 3 years will be included in this study.
Exclusion Criteria
- Selection will be based on the parent's willingness to allow their child to participate in the study.
- Children with diagnosed craniofacial syndromes will be excluded from the study due their higher than usual incidence of palatal fistulas.
- Children with known wound healing defects, such as Ehler Danlos syndrome, Pseudoxanthoma Elasticum, will be excluded from the study due to their inherent collagen defects and consequently on the incidence of palatal fistulas.
- Children with Veau class I cleft palates and those who will need/needed any surgical technique other then Furlow palatoplasty will be excluded from the study.
Data sourced from ClinicalTrials.gov (NCT01867632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.