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临床试验/NCT04554316
NCT04554316已完成不适用

Aesthetic Effect of Steri-Strip Orientation on Healing and Scar Appearance in Breast Surgery

Albert Einstein Healthcare Network4 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
4
主要终点
Cosmesis score 30 days

研究概览

简要总结

All patients undergoing breast biopsy, lumpectomy, needle-localization-guided breast biopsy, and mastectomy at Einstein Medical Center Philadelphia, Einstein Medical Center Montgomery, Center One, or Einstein Elkins Park will be offered participation into the study. Patients who have documented allergies to adhesive or tape, patients taking chronic steroids, and patients with documented connective tissue, skin, or healing disorders will be excluded from the study. Risks and benefits of the study as well as risks and benefits of the procedure will be discussed with the patient by one of the investigators. If the patient elects to participate in the study, they will be assigned to incisional dressing at the time of operation with either in-line or perpendicular placement of Steri-Strips based on the patient's computer-generated randomization assignment. The patient's chart will be reviewed to determine the patient's age and comorbid conditions including obesity (pre-operative BMI), diabetes mellitus, use of anti-platelet or anticoagulant medication, or smoking. This information will be utilized to ensure that our study groups are similar in baseline demographics and pre-existing conditions. Additionally, the primary medical reason for needing breast surgery will be reviewed as well as treatment with pre-operative or post-operative chemotherapy or radiation therapy to the breast. Steri-Strips will not be removed and will be allowed to fall off naturally. At regularly scheduled 30-day and 90-day follow-up appointments, pictures will be taken of the incisional area. These photographs will be reviewed by a blinded, independent surgeon who will grade each incision according to the modified Hollander Cosmesis Scale. Statistical analysis with t-testing of the means and chi-squared testing of dichotomous variables will be performed to determine significance of the findings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult patients undergoing breast biopsy, lumpectomy, needle-localization-guided breast biopsy, and mastectomy at Einstein Medical Center Philadelphia, Einstein Medical Center Montgomery, Center One, or Einstein Medical Center Elkins Park will be offered participation into the study.

排除标准

  • Patients who have documented allergies to adhesive or tape, patients taking chronic steroids, and patients with documented connective tissue, skin, or healing disorders
  • members of vulnerable populations such as adults who are unable to consent, individuals who are not yet adults, pregnant women, or prisoners

结局指标

主要结局

Cosmesis score 30 days

时间窗: 30 days

Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 30 days

Cosmesis score 90 days

时间窗: 90 days

Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 90 days

次要结局

  • Wound dehiscence(90 days)
  • Surgical site infection(90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Candace Ward

Principal Investigator

Albert Einstein Healthcare Network

研究点 (4)

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