NCT04554316

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

Completed NA Last updated 14 August 2023

What this trial tests

NA trial testing Steri-strip in Scar in 94 participants. Completed in 15 July 2023.

Timeline

1 November 2020

Primary endpoint
15 June 2023

15 July 2023

Quick facts

Lead sponsor	Albert Einstein Healthcare Network
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	94
Start date	1 November 2020
Primary completion	15 June 2023
Estimated completion	15 July 2023
Sites	2 locations across United States

Drugs / interventions tested

• Steri-strip

Conditions studied

• Scar — all drugs for Scar →
• Breast Neoplasms — all drugs for Breast Neoplasms →
• Breast Diseases — all drugs for Breast Diseases →
• Surgical Wound — all drugs for Surgical Wound →

Sponsor

Albert Einstein Healthcare Network

Who can join

18 and older, any sex, with Scar or Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.