Aesthetic Effect of Steri-Strip Orientation on Healing and Scar Appearance in Breast Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Parallel placement Steri-strips will be placed in-line (parallel) with the surgical incision. |
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.
|
| Active Comparator: Perpendicular placement Steri-strips will be placed perpendicular to the surgical incision. |
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.
|
Outcome Measures
Primary Outcome Measures
- Cosmesis score 30 days [30 days]
Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 30 days
- Cosmesis score 90 days [90 days]
Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 90 days
Secondary Outcome Measures
- Surgical site infection [90 days]
Presence or absence of surgical site infection
- Wound dehiscence [90 days]
Presence or absence of wound dehiscence
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Albert Einstein Medical Center Montgomery | East Norriton | Pennsylvania | United States | 19403 |
| 2 | Albert Einstein Medical Center | Philadelphia | Pennsylvania | United States | 19141 |
Sponsors and Collaborators
- Albert Einstein Healthcare Network
Investigators
- Principal Investigator: Candace L Ward, MD, MPH, Albert Einstein Medical Center Phialdelphia
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Katz KH, Desciak EB, Maloney ME. The optimal application of surgical adhesive tape strips. Dermatol Surg. 1999 Sep;25(9):686-8.
- Pushpakumar SB, Hanson RP, Carroll S. The application of Steri-Strips. Plast Reconstr Surg. 2004 Mar;113(3):1106-7.
- Rodeheaver GT, McLane M, West L, Edlich RF. Evaluation of surgical tapes for wound closure. J Surg Res. 1985 Sep;39(3):251-7.
- IRB-2019-118