- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07741591
Impact of Perioperative Antibiotic Use on Surgical Scarring (PASS)
Perioperative Antibiotic Use and Its Impact on Postoperative Scarring: A Retrospective Study
This retrospective observational cohort study will evaluate whether perioperative antibiotic use is associated with long-term surgical scar outcomes. The study will include adult patients who underwent body surface surgery at Nanfang Hospital between January 1, 2005 and January 1, 2025 and have available surgical, medication, and scar-related clinical records.
The study will not assign participants to any treatment. Researchers will review existing medical records, perioperative antibiotic exposure, surgical characteristics, complications, and scar assessments or photographs. Scar outcomes will be assessed using modified visual analogue scale scores, scar width, scar type, and scar-related complications.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Gaofeng Wang, Principal Investigator
- Número de teléfono: +86 13242749806
- Correo electrónico: Wenzhenli0526@163.com
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510515
- Nanfang Hospital, Southern Medical University
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Contacto:
- Gaofeng Wang, MD
- Número de teléfono: 86-13242749806
- Correo electrónico: wenzhenli0526@163.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age 18 years or older.
- Underwent body surface surgery at Nanfang Hospital between January 1, 2005 and January 1, 2025, with a linear surgical incision scar.
- Presented to the Department of Plastic Surgery at Nanfang Hospital for surgical scar-related care.
- Had no medical encounter record at Nanfang Hospital from January 1, 2025 to the time of study screening.
- Available clear surgical records and perioperative medication records.
Exclusion Criteria:
- Known tendency for pathological scarring or scar constitution.
- History of chronic skin disease in the surgical area, such as psoriasis or eczema.
- Uncontrolled diabetes mellitus, malnutrition, hypoalbuminemia, or long-term use of immunosuppressive agents or glucocorticoids.
- Target scar received any scar-specific treatment after surgery, such as laser therapy, radiotherapy, drug injection, or surgical revision.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Retrospective Surgical Scar Cohort
Adult patients who underwent body surface surgery at Nanfang Hospital between January 1, 2005 and January 1, 2025 and have available surgical records, perioperative medication records, and scar outcome information.
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Patterns of perioperative antibiotic use documented in existing medical records, including timing, indication, antibiotic type, duration, frequency, and route of administration.
No antibiotic treatment will be assigned or provided by the study.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Scar Appearance Score Assessed Using a Modified Visual Analogue Scale
Periodo de tiempo: Scar photographs were taken during postoperative clinical follow-up, with an overall range from 3 months to 20 years after surgery. Given the wide span, the assessments will be stratified and reported according to the actual time of photography, for exam
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Overall scar appearance will be evaluated from scar photographs by three blinded physicians or trained study personnel using a modified visual analogue scale.
Scores range from 1 to 10, with 1 indicating appearance similar to normal skin and 10 indicating the worst imaginable scar appearance.
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Scar photographs were taken during postoperative clinical follow-up, with an overall range from 3 months to 20 years after surgery. Given the wide span, the assessments will be stratified and reported according to the actual time of photography, for exam
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Scar Color Score Assessed Using a Modified Visual Analogue Scale
Periodo de tiempo: Scar photographs were taken during postoperative clinical follow-up, with an overall range from 3 months to 20 years after surgery. Given the wide span, the assessments will be stratified and reported according to the actual time of photography, for exam
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Scar color will be evaluated from scar photographs by three blinded physicians or trained study personnel using a modified visual analogue scale.
Scores range from 1 to 10, with lower scores indicating color more similar to normal skin and higher scores indicating worse scar color.
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Scar photographs were taken during postoperative clinical follow-up, with an overall range from 3 months to 20 years after surgery. Given the wide span, the assessments will be stratified and reported according to the actual time of photography, for exam
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Scar Texture Score Assessed Using a Modified Visual Analogue Scale
Periodo de tiempo: Scar photographs were taken during postoperative clinical follow-up, with an overall range from 3 months to 20 years after surgery. Given the wide span, the assessments will be stratified and reported according to the actual time of photography, for exam
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Scar texture will be evaluated from scar photographs by three blinded physicians or trained study personnel using a modified visual analogue scale.
Scores range from 1 to 10, with lower scores indicating texture more similar to normal skin and higher scores indicating worse scar texture.
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Scar photographs were taken during postoperative clinical follow-up, with an overall range from 3 months to 20 years after surgery. Given the wide span, the assessments will be stratified and reported according to the actual time of photography, for exam
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Scar Width
Periodo de tiempo: Scar photographs were taken during postoperative clinical follow-up, with an overall range from 3 months to 20 years after surgery. Given the wide span, the assessments will be stratified and reported according to the actual time of photography, for exam
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Scar width will be calculated from scar photographs by outlining the scar boundary and using ImageJ to measure scar area and scar length.
Scar width will be calculated as scar area divided by scar length.
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Scar photographs were taken during postoperative clinical follow-up, with an overall range from 3 months to 20 years after surgery. Given the wide span, the assessments will be stratified and reported according to the actual time of photography, for exam
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Scar-Related Complications
Periodo de tiempo: Postoperative days 0 to 30 (inclusive). The timing of each complication was determined from medical records.
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Scar-related complications will be identified from medical records and scar assessments, including wound dehiscence, suture reaction, necrosis, hematoma, infection, persistent itching, persistent pain, and sensory abnormalities.
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Postoperative days 0 to 30 (inclusive). The timing of each complication was determined from medical records.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- NFEC-2026-164
- MR-44-26-022534 (Otro identificador: National Health Commission, China)
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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