The Effect of Long-term Micropore Coverage on Cosmetic Outcomes After Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- SCAR score after 1 year
研究概览
简要总结
What is the purpose of this study? The Investigators want to find out whether applying Micropore surgical tape to the medial half of the mastectomy scar for 3 months helps improve its appearance after 12 months, compared to no intervention.
Why is this study important? Scars can cause discomfort and affect how people feel about their bodies. The tape is thought to reduce stress on healing skin and possibly lead to a better-looking scar. But The Investigators need strong evidence to know whether it really helps.
How will the study be done?
This is a randomized, observer-blinded trial.
Women having mastectomy are randomly assigned to either receive the tape on half their scar or receive no tape.
A plastic surgeon and a breast surgeon-who do not know which side had tape-will evaluate wounds using photos after 3 and 12 months.
Patients will also rate their scars using a questionnaire (POSAS), giving their personal view on color, thickness, stiffness, and symptoms like itch or pain.
What else are The Investigators looking at?
The Investigators will examine whether the treated half of the scar looks better than the untreated half within the same woman-this helps control for individual skin differences.
The Investigators will also compare treated versus untreated areas across different women to see if there is a consistent benefit.
If the untaped half of scars looks different from control scars, this may suggest differences between the groups that affect results.
What will this study reveal? It will show whether using the tape improves cosmetic outcomes after mastectomy, and whether patients and clinicians agree on how scars heal. The findings may guide better post-surgery care to reduce scars and improve confidence and quality of life.
详细描述
Detailed Description This study is a randomized, observer-blinded, controlled trial investigating whether application of Micropore surgical tape to the medial half of the mastectomy scar for three months results in improved long-term scar appearance compared to no intervention.
Background and Rationale Scarring after mastectomy can negatively affect body image, comfort, and quality of life. Various post-surgical dressings have been proposed to improve scar cosmesis, including paper-based adhesive tapes such as Micropore. The proposed mechanism is that such tapes may provide mechanical support to the healing wound, reduce tension across the incision, and create a stable microenvironment, thereby minimizing scar widening, irregularity, and discoloration.
While tape therapy is widely used in clinical practice, the evidence for its effectiveness in mastectomy scars is limited, and there is no consensus on its benefit in this context. This trial seeks to address this knowledge gap using a blinded photographic evaluation and patient-reported outcome measures.
Study Design
Participants are randomized in a 1:1 ratio to either:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing mastectomi without primary recontruction
- •BMI between 18-5 and 35
- •Age between 18 and 80
排除标准
- •Known bandaid allergy
- •In need of Mepilex Border OP after surgery
- •Concurrent treatment with systemic steroid treatment or other immunosuppresants
- •Post surgical haematoma that requires surgical intervention
- •Known tendency to kelloid or hypertrophic scar formation
研究组 & 干预措施
Micropore tape
Micropore covering of the medial half of the scar
干预措施: Micropore covering of the medial half of the scar (Other)
Control
Standart Practice
结局指标
主要结局
SCAR score after 1 year
时间窗: 1 year
Blinded observer score using The Scar Cosmesis Assessment and Rating (SCAR) scale to score surgical scar outcome from photos of the mastectomy incision at 12 months.
次要结局
- POSAS Score at 12 months(1 year)
研究者
Gustav Gede Nervil
Principal Investigator
Herlev Hospital