Aesthetic Effect of Steri-Strip Orientation on Healing and Scar Appearance in Breast Surgery
Primary Purpose
Scar, Breast Neoplasms, Breast Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Steri-strip
Sponsored by
About this trial
This is an interventional supportive care trial for Scar focused on measuring wound healing, cosmesis, postoperative dressing
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
Sites / Locations
- Albert Einstein Medical Center Montgomery
- Albert Einstein Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Parallel placement
Perpendicular placement
Arm Description
Steri-strips will be placed in-line (parallel) with the surgical incision.
Steri-strips will be placed perpendicular to the surgical incision.
Outcomes
Primary Outcome Measures
Cosmesis score 30 days
Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 30 days
Cosmesis score 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
Presence or absence of surgical site infection
Wound dehiscence
Presence or absence of wound dehiscence
Full Information
NCT ID
NCT04554316
First Posted
September 14, 2020
Last Updated
August 9, 2023
Sponsor
Albert Einstein Healthcare Network
1. Study Identification
Unique Protocol Identification Number
NCT04554316
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
July 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein Healthcare Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar, Breast Neoplasms, Breast Diseases, Surgical Wound
Keywords
wound healing, cosmesis, postoperative dressing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parallel placement
Arm Type
Active Comparator
Arm Description
Steri-strips will be placed in-line (parallel) with the surgical incision.
Arm Title
Perpendicular placement
Arm Type
Active Comparator
Arm Description
Steri-strips will be placed perpendicular to the surgical incision.
Intervention Type
Device
Intervention Name(s)
Steri-strip
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cosmesis score 30 days
Description
Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 30 days
Time Frame
30 days
Title
Cosmesis score 90 days
Description
Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 90 days
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Surgical site infection
Description
Presence or absence of surgical site infection
Time Frame
90 days
Title
Wound dehiscence
Description
Presence or absence of wound dehiscence
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candace L Ward, MD, MPH
Organizational Affiliation
Albert Einstein Medical Center Phialdelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein Medical Center Montgomery
City
East Norriton
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD with other researchers.
Citations:
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.
Results Reference
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PubMed Identifier
10491057
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.
Results Reference
background
PubMed Identifier
4033109
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.
Results Reference
background
PubMed Identifier
15108939
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.
Results Reference
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Aesthetic Effect of Steri-Strip Orientation on Healing and Scar Appearance in Breast Surgery
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