NCT06768047

Brief Summary

The aim of this study is to determine the effect of microporous taping on improving scar characteristics in post-surgical HTS.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

December 23, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

January 7, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2025

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

December 23, 2024

Last Update Submit

January 6, 2025

Conditions

Keywords

Microporous tapePost surgical hypertrophic scarsModified Vancouver Scar ScaleSchiotz tonometer.

Outcome Measures

Primary Outcomes (1)

  • Scars pliability

    A Schiotz tonometer device (Riester, Germany, 0124) is simple to use, in expensive, reliable, requires little time to maintain and does not require supply of batteries or electricity. It has a free-floating, rod-like plunger with a 5.5 gm weight attached fits inside the barrel and other weights (7.5 or 10 grams) are put that can be equipped to the plunger. A Schiotz tonometer device was used as an objective device to assess the hypertrophic scar's pliability and elasticity

    8 weeks

Study Arms (2)

Study group: receive Microporous tape and traditional physical therapy treatment

ACTIVE COMPARATOR
Other: Microporous tapeOther: Tradition physical therapy

Control group receive traditional therapy ( (deep friction massage and stretching exercises)

OTHER
Other: Tradition physical therapy

Interventions

Microporous tape is a dressing tape that was discovered to have scar modulating effects. It is made up of a conformable, inextensible, nonwoven fabric manufactured from 100% viscose and coated with a layer of acrylic adhesive. It is cheap, cost-effective, readily available, and relatively affordable for post surgical patients.

Study group: receive Microporous tape and traditional physical therapy treatment

Tradition physical therapy as stretching exercises and deep friction massage, Stretching is a form of physical exercise in which a specific muscle or tendon (or muscle group) is deliberately expanded and flexed in order to improve the muscle's felt elasticity and achieve comfortable muscle tone. The result is a feeling of increased muscle control, flexibility, and range of motion. Deep friction massage also known as cross friction massage, is a specific connective tissue massage which maintain the mobility within the soft tissue structures of ligament, tendon, and muscle, and prevent adherent scars from forming.

Control group receive traditional therapy ( (deep friction massage and stretching exercises)Study group: receive Microporous tape and traditional physical therapy treatment

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The patients' age will range from 20-45 years, and will be selected from both genders .
  • All patients will have hypertrophic scars after surgeries.
  • The general size of the scars will range from 5 to 7 cm'2

You may not qualify if:

  • The patients who will excluded from the study including those with infected post-operative wounds .
  • The patients whose wounds were closed secondarily or healed by secondary intention.
  • patients who are keloid formers.
  • Uncontrolled diabetes mellitus
  • Uncontrolled hypertension.
  • The patients who had a deep venous thrombosis (DVT).
  • Hypersensitivity reaction to Microporous tape.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Agrawal A, Ding J, Agrawal B, Kwan PO, Tredget EE. Stimulation of toll-like receptor pathways by burn eschar tissue as a possible mechanism for hypertrophic scarring. Wound Repair Regen. 2021 Sep;29(5):810-819. doi: 10.1111/wrr.12940. Epub 2021 May 27.

    PMID: 34043867BACKGROUND
  • Ogawa R, Akaishi S, Huang C, Dohi T, Aoki M, Omori Y, Koike S, Kobe K, Akimoto M, Hyakusoku H. Clinical applications of basic research that shows reducing skin tension could prevent and treat abnormal scarring: the importance of fascial/subcutaneous tensile reduction sutures and flap surgery for keloid and hypertrophic scar reconstruction. J Nippon Med Sch. 2011;78(2):68-76. doi: 10.1272/jnms.78.68.

    PMID: 21551963BACKGROUND

Related Links

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Hagar Mohammed El garahy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical therapist

Study Record Dates

First Submitted

December 23, 2024

First Posted

January 10, 2025

Study Start

January 7, 2025

Primary Completion

March 7, 2025

Study Completion

March 7, 2025

Last Updated

January 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share