Microporous Tape and Post Surgical Scars

January 6, 2025 updated by: Hagar Mohammed Hashem Elgarahy, Cairo University
The aim of this study is to determine the effect of microporous taping on improving scar characteristics in post-surgical HTS.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A scar can be defined as a mark or a blemish resulting from a healed wound. Scars are an integral part of human existence. All surgical incisions give rise to scars. Some scars are thin lines which are almost unnoticeable, whereas others become hypertrophic scars or keloids. Mechanical forces including tension have been shown to influence scarring as demonstrated in animal models and clinical experience. Wounds closed with excess tension are known to produce more scar tissue.A normal scar is characterized by minimal fibrosis; it is thin, flat and has a good colour match with the surrounding skin without distortion of the adjacent tissue. A scar is however considered abnormal when the amount of fibrosis is excessive or suboptimal or when it causes functional disability, psychosocial trauma or aesthetic distress to the patient. The conversion of normal scarring to hypertrophic scarring or the apparent overgrowth of scar support especially with the use of tape is critical during this period when increased tension across the scar would result in exaggerated scarring. The good management of scars is very important for patient to solve these consequences. Hypertrophic scars have seven times greater collagen production than normal due to increasing in collagenase activity. The hypertrophic scar develops at the third stage of wound healing. Scar maturation or remodeling lasts from three weeks to six months but may last for years.

The hypertrophic scars usually lead to connective tissue and muscles contracture resulting in limited R.O.M at the area of the scar Hypertrophic scars and keloids are Overgrowth of fibrous tissue that usually develop after healing of a skin injury and extend beyond the 2 original defect.

They often occur after local skin trauma as lacerations and burn injuries. Scarring following surgery or trauma is difficult to predict and physicians are highly concerned with minimizing scar appearance and value even small improvements in scarring as clinically meaningful.

to hypertrophic scarring or the apparent overgrowth of scar support especially with the use of tape is critical during this period when increased tension across the scar would result in exaggerated scarring. Hypertrophic scars cause cosmetic, psychological, physical (pain, and disabilities),financial and social consequences in addition to that , Hypertrophic scars lead to hypo-mobility ,connective tissue and muscles contracture.

The good management of scars is very important for patient to solve these consequences

.Hypertrophic scars have seven times greater collagen production than normal due to increasing in collagenase activity. The hypertrophic scar develops at the third stage of wound healing. Scar maturation or remodeling lasts from three weeks to six months but may last for years . The hypertrophic scar usually lead to connective tissue and muscles contracture resulting in limited R.O.M at the area of the scar Hypertrophic scars and keloids are Overgrowth of fibrous tissue that usually develop after healing of a skin injury and extend beyond the 2 original defect. They often occur after local skin trauma as lacerations and burn injuries . Scarring following surgery or trauma is difficult to predict and physicians are highly concerned with minimizing scar appearance and value even small improvements in scarring as clinically meaningful.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study group: receive Microporous tape and traditional physical therapy treatment
Other: Microporous tape
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.
Other: Tradition physical therapy

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.
Other: Control group receive traditional therapy ( (deep friction massage and stretching exercises)
Other: Tradition physical therapy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scars pliability
Time Frame: 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 7, 2025

Primary Completion (Estimated)

March 7, 2025

Study Completion (Estimated)

March 7, 2025

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Microporous tape and scars

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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