The Effect of Use of Dermal Fat Graft as a Barrier Membrane | NCT05334602

Studies
The Effect of Use of Dermal Fat Graft as a Barrier Membrane

NCT05334602

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Apr 19, 2022Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Unilateral Cleft Lip

Interventions

Addition of dermal fat graft as protection over bone graft

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2019Actual

Primary Completion Date

Mar 1, 2022Actual

Completion Date

Mar 1, 2022Actual

First Submitted Date

Apr 12, 2022

First Submission Date that Met QC Criteria

Apr 12, 2022

First Posted Date

Apr 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2022

Last Update Posted Date

Apr 19, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yasser Mohamed Nabil Ahmed Khirat El Hadidi, principle investigator, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

a study conducted to assess the use of dermal fat graft use as barrier membrane over grafted bone

Detailed Description

The study has two group in which the study will have in addition to the conventional bone grafting addition of dermal fat graft to protect the bone. The control will have just normal graft

The results are assessed using computed tomography to assess the quality of the grafted bone.

The Chisquare test was used to asses the results significance.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group	Experimental	Dermal fat graft is added over the grafted bone in the alveolar cleft to protect the bone from resorption	Procedure: Addition of dermal fat graft as protection over bone graft
control group	No Intervention	Conventional procedure of alveolar cleft grafting

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Addition of dermal fat graft as protection over bone graft	Procedure	A barrier membrane	study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of oronasal fistula	assessment of incidence of recurrence of oronasal fistual after the surgical procedure clinically	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients having age range of 8-14ys who performed for 2ry alveolar cleft grafting at the CCC using adipose fat graft in conjunction with ACBG Boys or girls. Unilateral or bilateral cleft alveolus. Accepts Healthy Volunteers has not been entered.

Exclusion Criteria:

Younger patients requiring 1ry grafting. Older patients requiring 3ry grafting.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marwa EL Kassaby	Ain Shams University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain shams University		Cairo		11757	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

RCT conducted to assess the effect of adding fat over bone graft in order to protect the bone from resorption

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided