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

NCT07744867 | Not Yet Recruiting

• 1 other identifier: SMC-3174-26
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Scars; Scars Formation

Keywords

Scars, Pressure garments, Silicone sheets, Combined therapy, Scar assessment, Skin elasticity, Limb scars

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Baseline, 1 month, 2 months, and 3 months after treatment initiation

Study Arms (2)

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.

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.

Other: Pressure Garment Therapy

Interventions

Pressure Garment Therapy OTHER

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.

Pressure Garment Therapy Alone

Pressure Garment and Silicone Sheet Therapy OTHER

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.

Combined Pressure Garment and Silicone Sheet Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Avi Avitan

CONTACT

+972 586503077; Avi.Avitan@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share