ScarsNCT07744867
The Study Examines the Efficacy of Treating Limb Scars Using a Combined Pressure Garment and Silicone Sheet Compared to Treatment With a Pressure Garment Alone. The Study Aims to Develop a Comprehensive Scar Assessment Framework, Integrating Objective and Subjective Tools to Evaluate Treatment
A study testing Pressure Garment and Silicone Sheet Therapy and Pressure Garment Therapy in people with Scars and Scars Formation, run by Sheba Medical Center.
Trial summary
Rehabilitation of traumatic and surgical limb scars commonly includes the use of pressure garments to improve scar maturation. Silicone sheets are also widely used in scar management; however, the additional benefit of combining silicone sheets with pressure garments has not been fully established. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Scars, Scars Formation
- What is being tested?
- Pressure Garment and Silicone Sheet Therapy and Pressure Garment Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 31 Dec 2028
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- Participants aged 18 to 65 years.
- Presence of a scar on an extremity.
- Scar length of at least 5 cm.
- Scar age of 1-6 months at the time of enrollment.
- Ability to understand and provide informed consent.
Who cannot join
- Scars crossing joints.
- Medical conditions affecting wound healing.
- Skin diseases in the scar area.
- Active infections.
- Known sensitivity or allergy to silicone.
- Neurological disorders affecting the involved extremity.
- -
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
Official title: The Efficacy of Combined Treatment Using Pressure Garments and Silicone Sheets in Treating Limb Scars, Compared to Treatment With Pressure Garments Alone.
Rehabilitation of traumatic and surgical limb scars commonly includes the use of pressure garments to improve scar maturation. Silicone sheets are also widely used in scar management; however, the additional benefit of combining silicone sheets with pressure garments has not been fully established. This study aims to evaluate the effectiveness of combined treatment with pressure garments and silicone sheets compared with treatment using pressure garments alone in adults with traumatic or surgical limb scars. Approximately 60 participants aged 18-65 years with scars 1-6 months after injury or surgery will be enrolled. Scar outcomes will be assessed using objective measures, including three-dimensional scar scanning, color assessment, and elasticity measurements, as well as the Patient and Observer Scar Assessment Scale (POSAS) version 2.0. The findings are expected to contribute to the development of a comprehensive scar assessment framework and improve evidence-based scar management.
Read the detailed description
Sixty participants with pathological scars of the extremities will be recruited from the Department of Occupational Therapy and Hand Therapy at Sheba Medical Center. Inclusion criteria will include individuals aged 18 to 65 years with extremity scars measuring at least 5 cm in length and a scar age of 1-6 months. Exclusion criteria will include scars crossing joints, underlying medical conditions affecting wound healing, skin diseases, active infections, silicone sensitivity, and neurological disorders. Participants will be allocated into two groups using a matching method according to age, sex, scar location, and skin tone to minimize potential confounding variables.
The study is designed as a prospective pre-post intervention study with repeated measurements and monthly follow-ups over a period of three months. Each participant will undergo an initial evaluation session documenting personal information, scar characteristics, and baseline scar assessment. Scar evaluation will include both objective and subjective outcome measures. Objective measurements will include scar height and area assessment using the EinScan HX® scanner, skin elasticity evaluation using the Cutometer®, color assessment using the Skin Colorimeter®, and validation of applied pressure using the Flexiforce® sensor to ensure an interfacial pressure of 15-25 mmHg. Subjective scar evaluation will be performed using the Patient and Observer Scar Assessment Scale (POSAS 3.0).
The intervention group will receive treatment using a combination of pressure garments and silicone sheets, while the control group will receive treatment using pressure garments alone. Both groups will receive instructions regarding scar management and proper use of the prescribed treatment. Participants will be followed monthly throughout the three-month intervention period, and repeated scar assessments will be performed to evaluate changes over time.
The primary aim of this study is to examine the efficacy of combined pressure garment and silicone sheet therapy compared to pressure garment therapy alone in the treatment of pathological scars of the extremities. In addition, the study aims to establish a comprehensive scar assessment framework integrating objective and subjective measures to improve the evaluation of scar characteristics and treatment outcomes.
- Conditions
- Scars, Scars Formation
- Being tested
- Pressure Garment and Silicone Sheet Therapy, Pressure Garment Therapy
- Keywords
- Scars, Pressure garments, Silicone sheets, Combined therapy, Scar assessment, Skin elasticity, Limb scars
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Garment and Silicone Sheet TherapyOther
Participants will receive combined scar treatment using pressure garments and silicone sheets. The treatment aims to improve scar characteristics, including height, area, elasticity, color, and overall scar quality. Participants will be followed for three months with repeated scar assessments.
Pressure Garment TherapyOther
Participants will receive scar treatment using pressure garments alone. The treatment aims to improve scar characteristics and overall scar quality. Participants will be followed for three months with repeated scar assessments.
| Study group | Role | What they receive |
|---|---|---|
| Combined Pressure Garment and Silicone Sheet Therapy | Experimental | Participants will receive combined scar treatment using pressure garments and silicone sheets. The intervention aims to improve scar characteristics, including height, area, elasticity, color, and overall scar quality. Participants will be followed for three months with repeated scar assessments. Receives: Other: Pressure Garment and Silicone Sheet Therapy |
| Pressure Garment Therapy Alone | Active comparator | Participants will receive scar treatment using pressure garments alone. Participants will be followed for three months with repeated scar assessments to evaluate changes in scar characteristics over time. Receives: Other: Pressure Garment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Scar Height, Area, Color, Elasticity, and Overall Scar Quality at 3 Months
Scar characteristics will be assessed using objective and subjective measures, including scar height and area (EinScan HX®), elasticity (Cutometer®), color (Skin Colorimeter®), and POSAS 3.0 score. Changes over time will be compared between the combined treatment group and the pressure garment group.
Measured: Change from Baseline in Scar Characteristics at 3 Months
Change in Scar Quality
Changes in scar characteristics will be evaluated over a three-month intervention period using a comprehensive assessment framework that includes objective and subjective outcome measures. Objective measures will include scar height and area assessed using the EinScan HX® scanner, scar elasticity assessed using the Cutometer®, and scar color assessed using the Skin Colorimeter®. Subjective scar quality will be assessed using the Patient and Observer Scar Assessment Scale (POSAS 3.0).
Measured: Baseline, 1 month, 2 months, and 3 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel-group interventional study. Participants will be allocated into two treatment groups using a matching method based on age, sex, scar location, and skin tone. The intervention group will receive combined treatment with pressure garments and silicone sheets, while the control group will receive treatment with pressure garments alone. Both groups will be followed for three months with repeated monthly scar assessments to evaluate changes in objective and subjective scar characteristics over time
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744867
- Sponsor's protocol ID
- SMC-3174-26
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only statistical outcome measure are to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Combined Treatment Using Pressure Garments and Silicone Sheets in Treating Limb Scars, Compared to Treatment With Pressure Garments Alone.
- ClinicalTrials.gov ID
- NCT07744867
- Acronym / sponsor ID
- SMC-3174-26
- Conditions
- Scars, Scars Formation
- Keywords
- Scars, Pressure garments, Silicone sheets, Combined therapy, Scar assessment, Skin elasticity, Limb scars
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Aug 2026 (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.
Rehabilitation of traumatic and surgical limb scars commonly includes the use of pressure garments to improve scar maturation. Silicone sheets are also widely used in scar management; however, the additional benefit of combining silicone sheets with pressure garments has not been fully established. This study aims to evaluate the effectiveness of combined treatment with pressure garments and silicone sheets compared with treatment using pressure garments alone in adults with traumatic or surgical limb scars. Approximately 60 participants aged 18-65 years with scars 1-6 months after injury or surgery will be enrolled. Scar outcomes will be assessed using objective measures, including three-dimensional scar scanning, color assessment, and elasticity measurements, as well as the Patient and Observer Scar Assessment Scale (POSAS) version 2.0. The findings are expected to contribute to the development of a comprehensive scar assessment framework and improve evidence-based scar management.
Detailed description
Sixty participants with pathological scars of the extremities will be recruited from the Department of Occupational Therapy and Hand Therapy at Sheba Medical Center. Inclusion criteria will include individuals aged 18 to 65 years with extremity scars measuring at least 5 cm in length and a scar age of 1-6 months. Exclusion criteria will include scars crossing joints, underlying medical conditions affecting wound healing, skin diseases, active infections, silicone sensitivity, and neurological disorders. Participants will be allocated into two groups using a matching method according to age, sex, scar location, and skin tone to minimize potential confounding variables.
The study is designed as a prospective pre-post intervention study with repeated measurements and monthly follow-ups over a period of three months. Each participant will undergo an initial evaluation session documenting personal information, scar characteristics, and baseline scar assessment. Scar evaluation will include both objective and subjective outcome measures. Objective measurements will include scar height and area assessment using the EinScan HX® scanner, skin elasticity evaluation using the Cutometer®, color assessment using the Skin Colorimeter®, and validation of applied pressure using the Flexiforce® sensor to ensure an interfacial pressure of 15-25 mmHg. Subjective scar evaluation will be performed using the Patient and Observer Scar Assessment Scale (POSAS 3.0).
The intervention group will receive treatment using a combination of pressure garments and silicone sheets, while the control group will receive treatment using pressure garments alone. Both groups will receive instructions regarding scar management and proper use of the prescribed treatment. Participants will be followed monthly throughout the three-month intervention period, and repeated scar assessments will be performed to evaluate changes over time.
The primary aim of this study is to examine the efficacy of combined pressure garment and silicone sheet therapy compared to pressure garment therapy alone in the treatment of pathological scars of the extremities. In addition, the study aims to establish a comprehensive scar assessment framework integrating objective and subjective measures to improve the evaluation of scar characteristics and treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a parallel-group interventional study. Participants will be allocated into two treatment groups using a matching method based on age, sex, scar location, and skin tone. The intervention group will receive combined treatment with pressure garments and silicone sheets, while the control group will receive treatment with pressure garments alone. Both groups will be followed for three months with repeated monthly scar assessments to evaluate changes in objective and subjective scar characteristics over time
| Arm | Type | Receives |
|---|---|---|
| Combined Pressure Garment and Silicone Sheet Therapy | Experimental | Other: Pressure Garment and Silicone Sheet TherapyParticipants will receive combined scar treatment using pressure garments and silicone sheets. The intervention aims to improve scar characteristics, including height, area, elasticity, color, and overall scar quality. Participants will be followed for three months with repeated scar assessments. |
| Pressure Garment Therapy Alone | Active comparator | Other: Pressure Garment TherapyParticipants will receive scar treatment using pressure garments alone. Participants will be followed for three months with repeated scar assessments to evaluate changes in scar characteristics over time. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- -
- Participants aged 18 to 65 years.
- Presence of a scar on an extremity.
- Scar length of at least 5 cm.
- Scar age of 1-6 months at the time of enrollment.
Key exclusion criteria (7 listed)
- Scars crossing joints.
- Medical conditions affecting wound healing.
- Skin diseases in the scar area.
- Active infections.
- Known sensitivity or allergy to silicone.
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 |
|---|---|---|
| Pressure Garment and Silicone Sheet TherapyParticipants will receive combined scar treatment using pressure garments and silicone sheets. The treatment aims to improve scar characteristics, including height, area, elasticity, color, and overall scar quality. Participants will be followed for three months with repeated scar assessments. | Other | Combined Pressure Garment and Silicone Sheet Therapy |
| Pressure Garment TherapyParticipants will receive scar treatment using pressure garments alone. The treatment aims to improve scar characteristics and overall scar quality. Participants will be followed for three months with repeated scar assessments. | Other | Pressure Garment Therapy Alone |
Primary outcome
Change from Baseline in Scar Height, Area, Color, Elasticity, and Overall Scar Quality at 3 Months
Time frame: Change from Baseline in Scar Characteristics at 3 Months
Scar characteristics will be assessed using objective and subjective measures, including scar height and area (EinScan HX®), elasticity (Cutometer®), color (Skin Colorimeter®), and POSAS 3.0 score. Changes over time will be compared between the combined treatment group and the pressure garment group.
Change in Scar Quality
Time frame: Baseline, 1 month, 2 months, and 3 months after treatment initiation
Changes in scar characteristics will be evaluated over a three-month intervention period using a comprehensive assessment framework that includes objective and subjective outcome measures. Objective measures will include scar height and area assessed using the EinScan HX® scanner, scar elasticity assessed using the Cutometer®, and scar color assessed using the Skin Colorimeter®. Subjective scar quality will be assessed using the Patient and Observer Scar Assessment Scale (POSAS 3.0).
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 4 Aug 2026.
- Individual participant dataSharing planned: No. Only statistical outcome measure are to be shared with other researchers.
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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 Pressure Garment and Silicone Sheet Therapy and Pressure Garment Therapy in people with Scars and Scars Formation, run by Sheba Medical Center.
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 6 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 4 Aug 2026. 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 Avi Avitan (+972 586503077, Avi.Avitan@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Scar Height, Area, Color, Elasticity, and Overall Scar Quality at 3 Months (time frame: Change from Baseline in Scar Characteristics at 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.