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Tape Application Protocol for Enhanced Scars

NCT07144046 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-08-27

No results posted yet for this study

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.

Conditions

  • Scar Improvement
  • Cosmetic Outcome

Interventions

OTHER

Micropore covering of the medial half of the scar

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

Sponsors & Collaborators

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • Gustav Nervil, MD, PhD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-09-01
Completion
2028-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07144046 on ClinicalTrials.gov