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

Official title

The Efficacy of Combined Treatment Using Pressure Garments and Silicone Sheets in Treating Limb Scars, Compared to Treatment With Pressure Garments Alone.

Overview

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.

Interventions

• Other Pressure Garment and Silicone Sheet Therapy
  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.
• Other Pressure Garment Therapy
  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.

Primary outcome measures

• 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]
• Change in Scar Quality [Time frame: Baseline, 1 month, 2 months, and 3 months after treatment initiation]

Eligibility criteria

Inclusion criteria

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Inclusion criteria

• 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.

Exclusion criteria

• 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.

Exclusion criteria

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07744867 · SMC-3174-26

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗