- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Istanbul
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Istanbul, Istanbul, 터키 (Türkiye), 34421
- Beyoglu Eye Training and Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative eyelid edema
기간: 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
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative pain
기간: Postoperative day 1
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Visual analogue scale (0-10)
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Postoperative day 1
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Patient comfort
기간: 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
기간: 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
기간: Postoperative days 1, 7, 30 and 90
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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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- BLF-25-01
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
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