Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-01 @ 6:28 AM
Study NCT ID:
NCT01867632
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2013-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acellular Dermal Matrix in Primary Palatoplasty
Sponsor:
Mirko S. Gilardino
Organization:
Study Overview
Official Title:
Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Palatoplasty
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: