- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Avi Avitan
- Telefonnummer: +972 586503077
- E-Mail: Avi.Avitan@sheba.health.gov.il
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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:
-
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Aktiver Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from Baseline in Scar Height, Area, Color, Elasticity, and Overall Scar Quality at 3 Months
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SMC-3174-26
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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