Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

29. Juli 2026 aktualisiert von: Sheba Medical Center

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

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.

Studienübersicht

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

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

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

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

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

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. August 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2028

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

29. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juli 2026

Zuerst gepostet (Tatsächlich)

4. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Only statistical outcome measure are to be shared with other researchers.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren