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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07701265
Does Unilateral Compression Dressing Reduce Postoperative Swelling and Bruising After Upper Eyelid Blepharoplasty? (COMPRESS-BLEPH)
The Effect of Compression Dressing on Postoperative Outcomes After Upper Eyelid Blepharoplasty: A Randomized, Controlled, Observer-Blinded Evaluation Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This was a prospective, randomized, controlled, observer-masked, within-subject (split-eye) trial conducted at a single academic center between June and November 2025. Adult patients with bilateral dermatochalasis scheduled for upper eyelid blepharoplasty were enrolled. Following bilateral surgery performed by a single surgeon, one eyelid of each patient was randomly assigned by coin toss to receive a compression dressing (folded sterile gauze secured with elastic tape, left in place for 24 hours), while the contralateral eyelid received no dressing and served as the internal control. All patients received standardized postoperative care, including bilateral cold compresses and topical medications.
Two masked investigators independently assessed postoperative edema (5-point ordinal scale), ecchymosis (ImageJ-based area quantification), and aesthetic outcome (Global Aesthetic Improvement Scale) from standardized clinical photographs obtained on postoperative days 1, 7, 30, and 90; disagreements were resolved by a third masked investigator. Postoperative pain (visual analog scale) and patient comfort preference were recorded on day 1. Best corrected visual acuity and corneal fluorescein staining (Oxford grading scale) were assessed at each follow-up visit to evaluate ocular surface safety. Between-group comparisons were performed using the Wilcoxon signed-rank test, with Holm-Bonferroni correction applied across outcomes at each visit to account for multiple comparisons.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul
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Istanbul, Istanbul, Turquía (Türkiye), 34421
- Beyoglu Eye Training and Research Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult patients (≥18 years) with bilateral upper eyelid dermatochalasis scheduled for upper eyelid blepharoplasty
- Willingness and ability to provide written informed consent
- Ability to comply with the postoperative follow-up schedule (postoperative days 1, 7, 30, and 90)
Exclusion Criteria:
- History of prior upper eyelid surgery
- Unilateral dermatochalasis
- Previous eyelid trauma
- Congenital eyelid anomalies
- Blepharochalasis syndrome
- Coagulopathy
- Combined indication for ptosis repair and blepharoplasty
- Severe bilateral visual impairment precluding safe application of compression dressing
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Compression Dressing (CD)
Upper eyelid randomly assigned to receive a compression dressing (folded sterile gauze secured with elastic tape) for 24 hours after surgery.
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A compression dressing consisting of folded sterile gauze pads followed by a dry gauze layer, secured with elastic tape (Clivex®, Climed Healthcare, Türkiye), applied to one upper eyelid immediately after bilateral upper eyelid blepharoplasty and left in place for 24 hours.
The contralateral eyelid remained uncovered and undressed, serving as the internal control.
|
|
Comparador activo: No Dressing (ND)
Contralateral upper eyelid receiving standard postoperative care without compression dressing, serving as the internal control.
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The contralateral upper eyelid received standard postoperative care without a compression dressing, remaining uncovered.
All other postoperative treatments (topical antibiotic ointment, cooling protocol, medications) were identical to the compression dressing side.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative eyelid edema
Periodo de tiempo: Postoperative day 1, postoperative day 7, postoperative day 30, postoperative day 90
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Standardized clinical photographs assessed by masked observers using a 5-point ordinal edema grading scale.
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Postoperative day 1, postoperative day 7, postoperative day 30, postoperative day 90
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Postoperative ecchymosis
Periodo de tiempo: Postoperative day 1, postoperative day 7, postoperative day 30, postoperative day 90
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Standardized clinical photographs analysed using ImageJ software and graded by masked observers.
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Postoperative day 1, postoperative day 7, postoperative day 30, postoperative day 90
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postoperative pain
Periodo de tiempo: Postoperative day 1
|
Visual analogue scale (0-10)
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Postoperative day 1
|
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Patient comfort
Periodo de tiempo: Postoperative day 1
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Patient questionnaire comparing comfort between the compression dressing and control eyelids.
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Postoperative day 1
|
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Corneal staining
Periodo de tiempo: Postoperative days 1, 7, 30 and 90
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Fluorescein staining graded according to the Oxford grading scale.
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Postoperative days 1, 7, 30 and 90
|
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Global aesthetic improvement
Periodo de tiempo: Postoperative days 1, 7, 30 and 90
|
Global Aesthetic Improvement Scale assessed by masked observers using standardized clinical photographs.
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Postoperative days 1, 7, 30 and 90
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Best corrected visual acuity
Periodo de tiempo: Baseline, postoperative days 1, 7, 30 and 90
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Best corrected visual acuity measured in logarithm of the minimum angle of resolution units.
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Baseline, postoperative days 1, 7, 30 and 90
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- BLF-25-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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