Tape Application Protocol for Enhanced Scars

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.

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