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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSheba Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Scars crossing joints.

Medical conditions affecting wound healing.

Skin diseases in the scar area.

Active infections.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pressure Garment and Silicone Sheet Therapy

    Other intervention

    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 Therapy

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Combined Pressure Garment and Silicone Sheet TherapyExperimental treatment 1 intervention
Group B: Pressure Garment Therapy AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Change from Baseline in Scar Characteristics at 3 Months
2

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).

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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