NCT07144046

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
29mo left

Started Sep 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Sep 2025Sep 2028

First Submitted

Initial submission to the registry

August 11, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

August 11, 2025

Last Update Submit

August 20, 2025

Conditions

Scar ImprovementCosmetic Outcome

Keywords

Cosmetic Scar EvaluationLong term wound dressingScar formationMastectomyBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • SCAR score after 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.

    1 year

Secondary Outcomes (1)

  • POSAS Score at 12 months

    1 year

Study Arms (2)

Micropore tape

ACTIVE COMPARATOR

Micropore covering of the medial half of the scar

Other: Micropore covering of the medial half of the scar

Control

NO INTERVENTION

Standart Practice

Interventions

Micropore covering of the medial half of the scarOTHER

3 months of micropore covering of the medial half of the scar

Also known as: Micropore
Micropore tape

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women undergoing mastectomi without primary recontruction
  • BMI between 18-5 and 35
  • Age between 18 and 80

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Micropore Filters

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

FiltrationChemistry Techniques, AnalyticalInvestigative TechniquesEquipment and Supplies

Study Officials

  • Gustav Nervil, MD, PhD

    STUDY DIRECTOR

Central Study Contacts

Gustav Nervil, MD, PhD

CONTACT

+4523711804gustavnervil@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 27, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

August 27, 2025

Record last verified: 2025-08