Scar ImprovementTAPESNCT07144046
Tape Application Protocol for Enhanced Scars
A study testing Micropore covering of the medial half of the scar in people with Scar Improvement and Cosmetic Outcome, run by Herlev Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Scar Improvement, Cosmetic Outcome
- What is being tested?
- Micropore covering of the medial half of the scar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women undergoing mastectomi without primary recontruction
- BMI between 18-5 and 35
- Age between 18 and 80
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Long-term Micropore Coverage on Cosmetic Outcomes After Mastectomy
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.
Read more
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.
Read the detailed description
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:
Intervention group: Application of Micropore tape to the medial half of the mastectomy scar for three months, starting approximately three weeks after surgery.
Control group: No application of Micropore tape; the scar remains uncovered after suture removal.
Block randomization in blocks of four will be used to maintain balanced group sizes over the course of enrollment. Randomization will be performed in REDCap, and allocation will occur after written informed consent is obtained.
Blinding Scar assessments will be conducted by two independent observers (a plastic surgeon and a breast surgeon) who are blinded to group allocation. Evaluations are based on standardized photographs taken at 3 and 12 months postoperatively. Medial and lateral halves of each scar will be assessed separately.
The lateral half of the scar in the intervention group is untreated and is expected to be comparable to the entire scar in the control group. Differences in lateral-half scores between groups will be examined to detect any systematic group imbalances.
Outcome Measures
Primary endpoint:
Difference in scar cosmesis at 12 months between intervention and control groups, based on the SCAR scale (observer-rated) and the Patient and Observer Scar Assessment Scale (POSAS, patient-reported component).
Secondary endpoints:
Within-subject difference between medial and lateral halves of the scar (intraindividual comparison).
Change in scores from 3 to 12 months for both observer and patient assessments.
Assessment of potential systematic differences between groups by comparing lateral halves across arms.
Concordance analysis between patient-reported scores (POSAS) and clinician-rated scores (SCAR) to evaluate agreement and identify systematic bias.
Follow-Up and Data Collection
At 3 months:
Standardized photographs
Patient questionnaire (POSAS)
Compliance assessment for the intervention group
At 12 months:
Standardized photographs
Patient questionnaire (POSAS)
Observer ratings (SCAR scale) of medial and lateral halves from photographs
Photographs are taken under standardized conditions: fixed camera distance (100 cm), controlled lighting, neutral background, and frontal plus 45° angled views.
- Conditions
- Scar Improvement, Cosmetic Outcome
- Being tested
- Micropore covering of the medial half of the scar
- Keywords
- Cosmetic Scar Evaluation, Long term wound dressing, Scar formation, Mastectomy, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropore covering of the medial half of the scarOther
Also called Micropore
3 months of micropore covering of the medial half of the scar
| Study group | Role | What they receive |
|---|---|---|
| Micropore tape | Active comparator | Micropore covering of the medial half of the scar Receives: Other: Micropore covering of the medial half of the scar |
| Control | No intervention | Standart Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
POSAS Score at 12 months
Patient and Observer Reported Outcome using The Patient and Observer Scar Assessment Scale (POSAS) at 12 months after surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar ImprovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustav Gede Nervil, Herlev Hospital
- Investigators
- Gustav Nervil, MD, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144046
- Sponsor's protocol ID
- TAPES
- Acronym
- TAPES
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Danish Data legislation makes sharing of patient data that can be tracked back to the individual patient illigal.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Long-term Micropore Coverage on Cosmetic Outcomes After Mastectomy
- ClinicalTrials.gov ID
- NCT07144046
- Acronym / sponsor ID
- TAPES / TAPES
- Conditions
- Scar Improvement, Cosmetic Outcome
- Keywords
- Cosmetic Scar Evaluation, Long term wound dressing, Scar formation, Mastectomy, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
Intervention group: Application of Micropore tape to the medial half of the mastectomy scar for three months, starting approximately three weeks after surgery.
Control group: No application of Micropore tape; the scar remains uncovered after suture removal.
Block randomization in blocks of four will be used to maintain balanced group sizes over the course of enrollment. Randomization will be performed in REDCap, and allocation will occur after written informed consent is obtained.
Blinding Scar assessments will be conducted by two independent observers (a plastic surgeon and a breast surgeon) who are blinded to group allocation. Evaluations are based on standardized photographs taken at 3 and 12 months postoperatively. Medial and lateral halves of each scar will be assessed separately.
The lateral half of the scar in the intervention group is untreated and is expected to be comparable to the entire scar in the control group. Differences in lateral-half scores between groups will be examined to detect any systematic group imbalances.
Outcome Measures
Primary endpoint:
Difference in scar cosmesis at 12 months between intervention and control groups, based on the SCAR scale (observer-rated) and the Patient and Observer Scar Assessment Scale (POSAS, patient-reported component).
Secondary endpoints:
Within-subject difference between medial and lateral halves of the scar (intraindividual comparison).
Change in scores from 3 to 12 months for both observer and patient assessments.
Assessment of potential systematic differences between groups by comparing lateral halves across arms.
Concordance analysis between patient-reported scores (POSAS) and clinician-rated scores (SCAR) to evaluate agreement and identify systematic bias.
Follow-Up and Data Collection
At 3 months:
Standardized photographs
Patient questionnaire (POSAS)
Compliance assessment for the intervention group
At 12 months:
Standardized photographs
Patient questionnaire (POSAS)
Observer ratings (SCAR scale) of medial and lateral halves from photographs
Photographs are taken under standardized conditions: fixed camera distance (100 cm), controlled lighting, neutral background, and frontal plus 45° angled views.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micropore tape | Active comparator | Other: Micropore covering of the medial half of the scarMicropore covering of the medial half of the scar |
| Control | No intervention | –Standart Practice |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women undergoing mastectomi without primary recontruction
- BMI between 18-5 and 35
- Age between 18 and 80
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micropore covering of the medial half of the scarAlso: Micropore3 months of micropore covering of the medial half of the scar | Other | Micropore tape |
Primary outcome
SCAR score after 1 year
Time frame: 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 secondary outcome
POSAS Score at 12 months
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: Undecided. Danish Data legislation makes sharing of patient data that can be tracked back to the individual patient illigal.
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Effectiveness of Radiofrequency Combined With Ultrasound for the Treatment of Postpartum Dyspareunia
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Hysteroscopic "360°" Surgery for Improvement of Symptoms in Cesarean Scar Defects
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AV-23-001 AVAVA MIRIA Pilot Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gustav Nervil, MD, PhD study director
Questions about this trial
What is this clinical trial studying?
A study testing Micropore covering of the medial half of the scar in people with Scar Improvement and Cosmetic Outcome, run by Herlev Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gustav Nervil, MD, PhD (+4523711804, gustavnervil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCAR score after 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.