NCT04554316

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Albert Einstein Healthcare Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Scar
• Breast Neoplasms
• Breast Diseases
• Surgical Wound

Interventions

Type	Name	Description
DEVICE	Steri-strip	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.

Timeline

• Start date: 2020-11-01
• Primary completion: 2023-06-15
• Completion: 2023-07-15
• First posted: 2020-09-18
• Last updated: 2023-08-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study