- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Gaofeng Wang, Principal Investigator
- Номер телефона: +86 13242749806
- Электронная почта: Wenzhenli0526@163.com
Места учебы
-
-
Guangdong
-
Guangzhou, Guangdong, Китай, 510515
- Nanfang Hospital, Southern Medical University
-
Контакт:
- Gaofeng Wang, MD
- Номер телефона: 86-13242749806
- Электронная почта: wenzhenli0526@163.com
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
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.
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Overall Scar Appearance Score Assessed Using a Modified Visual Analogue Scale
Временное ограничение: 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.
|
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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Scar Color Score Assessed Using a Modified Visual Analogue Scale
Временное ограничение: 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
Временное ограничение: 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
|
|
Scar Width
Временное ограничение: 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.
|
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-Related Complications
Временное ограничение: Postoperative days 0 to 30 (inclusive). The timing of each complication was determined from medical records.
|
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.
|
Postoperative days 0 to 30 (inclusive). The timing of each complication was determined from medical records.
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- NFEC-2026-164
- MR-44-26-022534 (Другой идентификатор: National Health Commission, China)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .