Trial Outcomes & Findings for Acellular Dermal Matrix in Primary Palatoplasty (NCT NCT01867632)
NCT ID: NCT01867632
Last Updated: 2017-07-21
Results Overview
Number of patients who developed post palatoplasty fistula
Recruitment status
COMPLETED
Target enrollment
131 participants
Primary outcome timeframe
Within 1 year of surgery
Results posted on
2017-07-21
Participant Flow
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
66
|
|
Overall Study
COMPLETED
|
65
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prospective Group
n=65 Participants
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.
|
Retrospective Group
n=66 Participants
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).
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.3 weeks
STANDARD_DEVIATION 25 • n=65 Participants
|
66.6 weeks
STANDARD_DEVIATION 27.1 • n=66 Participants
|
63 weeks
STANDARD_DEVIATION 26.3 • n=131 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=65 Participants
|
36 Participants
n=66 Participants
|
69 Participants
n=131 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=65 Participants
|
30 Participants
n=66 Participants
|
62 Participants
n=131 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Within 1 year of surgeryNumber of patients who developed post palatoplasty fistula
Outcome measures
| Measure |
Prospective Group
n=65 Participants
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.
|
Retrospective Group
n=66 Participants
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).
|
|---|---|---|
|
Fistula Formation
|
1 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Within 1 year of surgeryNumber of Participants with Wound Infection post cleft palate repair
Outcome measures
| Measure |
Prospective Group
n=65 Participants
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.
|
Retrospective Group
n=66 Participants
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).
|
|---|---|---|
|
Number of Participants With Wound Infection
|
0 Participants
|
0 Participants
|
Adverse Events
Prospective Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Retrospective Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place