- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Gaofeng Wang, Principal Investigator
- 전화번호: +86 13242749806
- 이메일: Wenzhenli0526@163.com
연구 장소
-
-
Guangdong
-
Guangzhou, Guangdong, 중국, 510515
- Nanfang Hospital, Southern Medical University
-
연락하다:
- Gaofeng Wang, MD
- 전화번호: 86-13242749806
- 이메일: wenzhenli0526@163.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Scar Appearance Score Assessed Using a Modified Visual Analogue Scale
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Scar Color Score Assessed Using a Modified Visual Analogue Scale
기간: 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
기간: 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
기간: 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
기간: 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.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- NFEC-2026-164
- MR-44-26-022534 (기타 식별자: National Health Commission, China)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .