- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07744867
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
The Efficacy of Combined Treatment Using Pressure Garments and Silicone Sheets in Treating Limb Scars, Compared to Treatment With Pressure Garments Alone.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Avi Avitan
- Telefoonnummer: +972 586503077
- E-mail: Avi.Avitan@sheba.health.gov.il
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
-
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:
-
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Combined Pressure Garment and Silicone Sheet Therapy
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.
|
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.
|
|
Actieve vergelijker: Pressure Garment Therapy Alone
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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from Baseline in Scar Height, Area, Color, Elasticity, and Overall Scar Quality at 3 Months
Tijdsspanne: 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 from Baseline in Scar Characteristics at 3 Months
|
|
Change in Scar Quality
Tijdsspanne: 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).
|
Baseline, 1 month, 2 months, and 3 months after treatment initiation
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SMC-3174-26
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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