NCT05293652

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

March 7, 2022

Last Update Submit

March 19, 2022

Conditions

ScarHydrocortisoneIontophoresisPhonophoresis

Outcome Measures

Primary Outcomes (1)

  • Scar pliability

    assessment of change in Scar pliability by using tonometer device

    at baseline and after 3 months of intervention

Study Arms (3)

Iontophosresis group

EXPERIMENTAL
Other: IontophoresisOther: traditional PT program

Phonophoresis group

EXPERIMENTAL
Other: PhonophoresisOther: traditional PT program

Traditional group

EXPERIMENTAL
Other: traditional PT program

Interventions

IontophoresisOTHER

Hydrocortisone iontophoresis

Iontophosresis group
PhonophoresisOTHER

Hydrocortisone Phonophoresis

Phonophoresis group
traditional PT programOTHER

Ultrasound and deep friction massage

Iontophosresis groupPhonophoresis groupTraditional group

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt

Damietta, 34518, Egypt

Location

MeSH Terms

Conditions

Cicatrix

Interventions

IontophoresisPhonophoresis

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsElectrophoresisElectrochemical TechniquesInvestigative Techniques

Study Officials

  • Mohamed Abdelnaser, Assistant lecturer

    Horus University in Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 24, 2022

Study Start

September 1, 2021

Primary Completion

January 15, 2022

Study Completion

February 15, 2022

Last Updated

March 24, 2022

Record last verified: 2022-03

Locations

EG(1)