- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Gaofeng Wang, Principal Investigator
- Numéro de téléphone: +86 13242749806
- E-mail: Wenzhenli0526@163.com
Lieux d'étude
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Guangdong
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Guangzhou, Guangdong, Chine, 510515
- Nanfang Hospital, Southern Medical University
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Contact:
- Gaofeng Wang, MD
- Numéro de téléphone: 86-13242749806
- E-mail: wenzhenli0526@163.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Scar Appearance Score Assessed Using a Modified Visual Analogue Scale
Délai: 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
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Scar Color Score Assessed Using a Modified Visual Analogue Scale
Délai: 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
|
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.
|
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
|
|
Scar Texture Score Assessed Using a Modified Visual Analogue Scale
Délai: 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
|
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.
|
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
Délai: 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
|
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
Délai: 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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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- NFEC-2026-164
- MR-44-26-022534 (Autre identifiant: National Health Commission, China)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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