Microporous TapeNCT06768047
Microporous Tape and Post Surgical Scars
A study testing Microporous tape and Tradition physical therapy in people with Microporous Tape and Hypertrophic Scars, run by Cairo University.
Trial summary
The aim of this study is to determine the effect of microporous taping on improving scar characteristics in post-surgical HTS. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Microporous Tape, Hypertrophic Scars
- What is being tested?
- Microporous tape and Tradition physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2025to 7 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to determine the effect of microporous taping on improving scar characteristics in post-surgical HTS.
Read the 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.
- Conditions
- Microporous Tape, Hypertrophic Scars
- Being tested
- Microporous tape, Tradition physical therapy
- Keywords
- Microporous tape, Post surgical hypertrophic scars, Modified Vancouver Scar Scale, Schiotz tonometer.
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microporous tapeOther
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.
Tradition physical therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group: receive Microporous tape and traditional physical therapy treatment | Active comparator | Not described Receives: Other: Microporous tape; Other: Tradition physical therapy |
| Control group receive traditional therapy ( (deep friction massage and stretching exercises) | Other | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start7 Jan 2025 (estimated)
- Primary completion7 Mar 2025 (estimated)
- Study completion7 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Microporous TapeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Mohammed Hashem Elgarahy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768047
- Sponsor's protocol ID
- Microporous tape and scars
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 34043867Ogawa 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.
PubMed 21551963
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microporous Tape and Post Surgical Scars
- ClinicalTrials.gov ID
- NCT06768047
- Acronym / sponsor ID
- Microporous tape and scars
- Conditions
- Microporous Tape, Hypertrophic Scars
- Keywords
- Microporous tape, Post surgical hypertrophic scars, Modified Vancouver Scar Scale, Schiotz tonometer.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Jan 2025 (estimated)
- Primary completion
- 7 Mar 2025 (estimated)
- Study completion
- 7 Mar 2025 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the effect of microporous taping on improving scar characteristics in post-surgical HTS.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group: receive Microporous tape and traditional physical therapy treatment | Active comparator | Other: Microporous tape, Other: Tradition physical therapy |
| Control group receive traditional therapy ( (deep friction massage and stretching exercises) | Other | – |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microporous tapeMicroporous 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 | Study group: receive Microporous tape and traditional physical therapy treatment |
| Tradition physical therapyTradition 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 | Study group: receive Microporous tape and traditional physical therapy treatment |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Results publication: PubMed 34043867Agrawal 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.
- Results publication: PubMed 21551963Ogawa 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Microporous tape and Tradition physical therapy in people with Microporous Tape and Hypertrophic Scars, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hagar Mohammed El garahy (01025582844, gegemouhmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scars pliability (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06768047, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.