Effect of Hydrocortisone Iontophoresis Versus Hydrocortis... | NCT05293652

Studies
Effect of Hydrocortisone Iontophoresis Versus Hydrocortisone Phonophoresis On Post Surgical Scar

NCT05293652

Sponsor

Horus University

Status

Completed

Last Update Posted

Mar 24, 2022Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Scar
Hydrocortisone
Iontophoresis
Phonophoresis

Interventions

Iontophoresis
Phonophoresis
traditional PT program

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

Mar 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

Sep 1, 2021Actual

Primary Completion Date

Jan 15, 2022Actual

Completion Date

Feb 15, 2022Actual

First Submitted Date

Mar 7, 2022

First Submission Date that Met QC Criteria

Mar 19, 2022

First Posted Date

Mar 24, 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

Mar 19, 2022

Last Update Posted Date

Mar 24, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Abd Elnaser Abd Elfattah Ghareeb, Principal investigator, Horus UniversityPrincipal Investigator

Lead Sponsor

Horus 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

The purpose of this study will be to compare the effect of hydrocortisone iontophoresis and hydrocortisone phonophoresis on the treatment of surgical scar and overall scar appearance.

Detailed Description

Scar contractures develop and extend to the underlying connective tissue and then muscles, leading to reduction in joint range of motion and affecting the day-to-day activities.

Most patients (irrespective of age, gender and ethnicity) believe that even a small improvement in scarring is worthwhile , any research that may help improve scar outcome is meaningful.

The need of this study has developed from the rarity of information about the difference between the effectiveness of iontophoresis and phonophoresis in enhancing the overall appearance of surgical scar.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Iontophosresis group	Experimental	Other: Iontophoresis Other: traditional PT program
Phonophoresis group	Experimental	Other: Phonophoresis Other: traditional PT program
Traditional group	Experimental	Other: traditional PT program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iontophoresis	Other	Hydrocortisone iontophoresis	Iontophosresis group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Scar pliability	assessment of change in Scar pliability by using tonometer device	at baseline and after 3 months of intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Both genders
same approach of medications
scar size varies from 5-15 cm

Exclusion Criteria:

have cardiac / pacemakers
have significant health problems
obese patients (BMI more than 30)
uncooperative patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohamed Abdelnaser, Assistant lecturer	Horus University in Egypt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt		Damietta		34518	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D002921	Cicatrix

Ancestor Terms

ID	Term
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007478	Iontophoresis
D015612	Phonophoresis

Ancestor Terms

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics
D004586	Electrophoresis

Browse Leaves

Not provided

Browse Branches

Not provided