Cleft Palate
Conditions
Keywords
Palatoplasty, Acellular Dermal Matrix
Brief 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.
Detailed description
There has been a change in the standard practice at the Montreal Children's Hospital where the senior author has shifted from selected application of ADM in certain cases to routine use of ADM in all cleft palate cases. This study is an observational study comparing a prospective cohort group receiving ADM routinely to a retrospective historical cohort group without routine use of ADM. Objectives of the study: Primary objectives: The primary objective of this study is to determine whether routine use of ADM would lower the incidence of palatal fistula in patients undergoing primary cleft palate repair. Secondary objectives: 1. Incidence of wound dehiscence 2. Incidence of wound infection 3. Hospital length of stay
Interventions
DEVICEAcellular Dermal Matrix
Sponsors
Mirko S. Gilardino
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
3 Months to 3 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fistula Formation | Within 1 year of surgery | Number of patients who developed post palatoplasty fistula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Wound Infection | Within 1 year of surgery | Number of Participants with Wound Infection post cleft palate repair |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prospective Group Prospective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate. | 65 |
| Retrospective Group Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft). | 66 |
| Total | 131 |
Baseline characteristics
| Characteristic | Prospective Group | Retrospective Group | Total |
|---|---|---|---|
| Age, Continuous | 59.3 weeks STANDARD_DEVIATION 25 | 66.6 weeks STANDARD_DEVIATION 27.1 | 63 weeks STANDARD_DEVIATION 26.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 33 Participants | 36 Participants | 69 Participants |
| Sex: Female, Male Male | 32 Participants | 30 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Fistula Formation
Number of patients who developed post palatoplasty fistula
Time frame: Within 1 year of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prospective Group | Fistula Formation | 1 participants |
| Retrospective Group | Fistula Formation | 8 participants |
Secondary
Number of Participants With Wound Infection
Number of Participants with Wound Infection post cleft palate repair
Time frame: Within 1 year of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Group | Number of Participants With Wound Infection | 0 Participants |
| Retrospective Group | Number of Participants With Wound Infection | 0 Participants |