Clinical trial · Interventional
Tape Application Protocol for Enhanced Scars
The Effect of Long-term Micropore Coverage on Cosmetic Outcomes After Mastectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cosmetic Outcome | — | UNRESOLVED | — |
| Scar Improvement | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Micropore covering of the medial half of the scar | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Micropore tape
- description
- Micropore covering of the medial half of the scar
- interventionNames
- Other: Micropore covering of the medial half of the scar
- type
- NO_INTERVENTION
- label
- Control
- description
- Standart Practice
Primary outcomes (1)
- measure
- SCAR score after 1 year
- timeFrame
- 1 year
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Women undergoing mastectomi without primary recontruction * BMI between 18-5 and 35 * Age between 18 and 80 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available