Aesthetic Effect of Steri-Strip Orientation on Healing and Scar Appearance in Breast Surgery

Study Overview
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Brief Summary
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All patients undergoing breast biopsy, lumpectomy, needle-localization-guided breast biopsy, and mastectomy at Einstein Medical Center Philadelphia, Einstein Medical Center Montgomery, Center One, or Einstein Elkins Park will be offered participation into the study. Patients who have documented allergies to adhesive or tape, patients taking chronic steroids, and patients with documented connective tissue, skin, or healing disorders will be excluded from the study. Risks and benefits of the study as well as risks and benefits of the procedure will be discussed with the patient by one of the investigators. If the patient elects to participate in the study, they will be assigned to incisional dressing at the time of operation with either in-line or perpendicular placement of Steri-Strips based on the patient's computer-generated randomization assignment. The patient's chart will be reviewed to determine the patient's age and comorbid conditions including obesity (pre-operative BMI), diabetes mellitus, use of anti-platelet or anticoagulant medication, or smoking. This information will be utilized to ensure that our study groups are similar in baseline demographics and pre-existing conditions. Additionally, the primary medical reason for needing breast surgery will be reviewed as well as treatment with pre-operative or post-operative chemotherapy or radiation therapy to the breast. Steri-Strips will not be removed and will be allowed to fall off naturally. At regularly scheduled 30-day and 90-day follow-up appointments, pictures will be taken of the incisional area. These photographs will be reviewed by a blinded, independent surgeon who will grade each incision according to the modified Hollander Cosmesis Scale. Statistical analysis with t-testing of the means and chi-squared testing of dichotomous variables will be performed to determine significance of the findings.

Official Title
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Aesthetic Effect of Steri-Strip Orientation on Healing and Scar Appearance in Breast Surgery

Conditions
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Scar, Breast Neoplasms, Breast Diseases, Surgical Wound

Intervention / Treatment
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* Device: Steri-strip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - All adult patients undergoing breast biopsy, lumpectomy, needle-localization-guided breast biopsy, and mastectomy at Einstein Medical Center Philadelphia, Einstein Medical Center Montgomery, Center One, or Einstein Medical Center Elkins Park will be offered participation into the study. Exclusion Criteria: Patients who have documented allergies to adhesive or tape, patients taking chronic steroids, and patients with documented connective tissue, skin, or healing disorders members of vulnerable populations such as adults who are unable to consent, individuals who are not yet adults, pregnant women, or prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parallel placement<br>Steri-strips will be placed in-line (parallel) with the surgical incision. | Device: Steri-strip<br>* Steri-Strips (3M Health Care, St. Paul, Minn) are a commonly used means of covering surgical incisions following many operations. Use of adhesive surgical tape over incisions maintains epidermal approximation in primary skin closure while limiting exposure to the environment, theoretically improving cosmesis and limiting risk of infection.<br>|
| Active Comparator: Perpendicular placement<br>Steri-strips will be placed perpendicular to the surgical incision. | Device: Steri-strip<br>* Steri-Strips (3M Health Care, St. Paul, Minn) are a commonly used means of covering surgical incisions following many operations. Use of adhesive surgical tape over incisions maintains epidermal approximation in primary skin closure while limiting exposure to the environment, theoretically improving cosmesis and limiting risk of infection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmesis score 30 days | Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 30 days | 30 days | 
| Cosmesis score 90 days | Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 90 days | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | Presence or absence of surgical site infection | 90 days | 
| Wound dehiscence | Presence or absence of wound dehiscence | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound healing, cosmesis, postoperative dressing