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

NCT04554316 | Completed FDA Device

• 1 other identifier: IRB-2019-118
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

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.

Conditions

Scar; Breast Neoplasms; Breast Diseases; Surgical Wound

Keywords

wound healing; cosmesis; postoperative dressing

Outcome Measures

Primary Outcomes (2)

• Cosmesis score 30 days

  Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 30 days

  30 days

• Cosmesis score 90 days

  Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 90 days

  90 days

Secondary Outcomes (2)

• Surgical site infection

  90 days

• Wound dehiscence

  90 days

Study Arms (2)

Parallel placement

ACTIVE COMPARATOR

Steri-strips will be placed in-line (parallel) with the surgical incision.

Device: Steri-strip

Perpendicular placement

ACTIVE COMPARATOR

Steri-strips will be placed perpendicular to the surgical incision.

Device: Steri-strip

Interventions

Steri-strip DEVICE

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.

Parallel placement; Perpendicular placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (2)

Albert Einstein Medical Center Montgomery

East Norriton, Pennsylvania, 19403, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Related Publications (4)

• 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.

  BACKGROUND

• 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.

  PMID: 10491057 BACKGROUND

• 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.

  PMID: 4033109 BACKGROUND

• 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.

  PMID: 15108939 BACKGROUND

MeSH Terms

Conditions

Cicatrix; Breast Neoplasms; Breast Diseases; Surgical Wound

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• Candace L Ward, MD, MPH

  Albert Einstein Medical Center Phialdelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 18, 2020
• Study Start: November 1, 2020
• Primary Completion: June 15, 2023
• Study Completion: July 15, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)