Clinical trial NCT04554316: Aesthetic Effect of Steri-Strip Orientation on Healing and Scar Appearance in Breast Surgery
Official title: Aesthetic Effect of Steri-Strip Orientation on Healing and Scar Appearance in Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar
Breast Neoplasms
Breast Diseases
Surgical Wound
Keywords: wound healing
cosmesis
postoperative dressing
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cosmesis score 30 days
timeFrame: 30 days
measure: Cosmesis score 90 days
timeFrame: 90 days
Secondary outcomes:
measure: Surgical site infection
timeFrame: 90 days
measure: Wound dehiscence
timeFrame: 90 days
Other outcomes:
Locations:
city: East Norriton
country: United States
facility: Albert Einstein Medical Center Montgomery
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
Study officials:
affiliation: Albert Einstein Medical Center Phialdelphia
name: Candace L Ward, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 3M Critical and Chronic Care Solutions Division. 3M Steri-Strip Adhesive Skin Closures Application and Removal Pocket Guide. 3M Steri-Strip Adhesive Skin Closures Application and Removal Pocket Guide, 3M, 2013.
citation: Katz KH, Desciak EB, Maloney ME. The optimal application of surgical adhesive tape strips. Dermatol Surg. 1999 Sep;25(9):686-8. doi: 10.1046/j.1524-4725.1999.99084.x.
citation: Rodeheaver GT, McLane M, West L, Edlich RF. Evaluation of surgical tapes for wound closure. J Surg Res. 1985 Sep;39(3):251-7. doi: 10.1016/0022-4804(85)90150-7.
citation: Pushpakumar SB, Hanson RP, Carroll S. The application of Steri-Strips. Plast Reconstr Surg. 2004 Mar;113(3):1106-7. doi: 10.1097/01.prs.0000107747.92015.b7. No abstract available.