Functional Outcome of Free Muscle Flaps Versus Free Skin... | NCT03152812

Studies
Functional Outcome of Free Muscle Flaps Versus Free Skin Flaps for Post-traumatic Foot Plantar Surface Reconstruction

NCT03152812

Sponsor

alhussein Ahmed Mahmoud El-Dahshan

Status

Unknown status

Last Update Posted

May 23, 2017Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Best Tissue Constituent for Plantar Surface

Interventions

plantar surface reconstruction by free flaps

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

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Mar 2019Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

May 12, 2017

First Submission Date that Met QC Criteria

May 12, 2017

First Posted Date

May 15, 2017Actual

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

May 20, 2017

Last Update Posted Date

May 23, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

alhussein Ahmed Mahmoud El-Dahshan, Principal investigator, Assiut UniversitySponsor-Investigator

Lead Sponsor

alhussein Ahmed Mahmoud El-DahshanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

the investigators are trying to detect what is the best tissue constituent suitable for reconstruction of large post traumatic sof tissue defects of foot plantar surface

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
free skin flaps			Procedure: plantar surface reconstruction by free flaps
free muscle flaps			Procedure: plantar surface reconstruction by free flaps

Interventions

Name	Type	Description	Arm Group Labels	Other Names
plantar surface reconstruction by free flaps	Procedure	use of free skin or free muscle flaps for reconstruction of plantar surface	free muscle flaps free skin flaps

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to mobilize		2 years
Requirement of specialized Footwear		2 years

Secondary Outcomes

Measure	Description	Time Frame
flap ulceration		2 years
Shear forces across the flap		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Posttraumatic large soft tissue defects of plantar surface requiring free tissue transfer for coverage
At any age

Exclusion Criteria:

1-defects that can be managed by local flaps 2-Non traumatic soft tissue defects

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

any individual having post traumatic soft tissue defect of plantar surface requiring free flap reconstruction regardless to age

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amr El-Said Ali Ibrahim, MD	Assiut University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University		Asyut	Asyut Governorate	7771	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided