ScarNCT04554316
Aesthetic Effect of Steri-Strip Orientation on Healing and Scar Appearance in Breast Surgery
A study testing Steri-strip in people with Scar and Breast Neoplasms, run by Albert Einstein Healthcare Network at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scar, Breast Neoplasms, Breast Diseases
- What is being tested?
- Steri-strip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2020to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Albert Einstein Medical Center Montgomery
East Norriton, Pennsylvania, 19403
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
About this study
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
- Being tested
- Steri-strip
- Keywords
- wound healing, cosmesis, postoperative dressing
- Medical subject headings
- Cicatrix, Breast Neoplasms, Breast Diseases, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steri-stripDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Parallel placement | Active comparator | Steri-strips will be placed in-line (parallel) with the surgical incision. Receives: Device: Steri-strip |
| Perpendicular placement | Active comparator | Steri-strips will be placed perpendicular to the surgical incision. Receives: Device: Steri-strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmesis score 30 days
Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 30 days
Measured: 30 days
Cosmesis score 90 days
Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 90 days
Measured: 90 days
Secondary outcomes (2)
Surgical site infection
Presence or absence of surgical site infection
Measured: 90 days
Wound dehiscence
Presence or absence of wound dehiscence
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Nov 2020
- Primary completion15 Jun 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candace Ward, Albert Einstein Healthcare Network
- Investigators
- Candace L Ward, MD, MPH, Principal investigator, Albert Einstein Medical Center Phialdelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554316
- Sponsor's protocol ID
- IRB-2019-118
- Status last verified
- Aug 2023
- First submitted
- 14 Sep 2020
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share IPD with other researchers.
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. doi: 10.1046/j.1524-4725.1999.99084.x.
PubMed 10491057Rodeheaver 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.
PubMed 4033109Pushpakumar 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.
PubMed 15108939
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Effect of Steri-Strip Orientation on Healing and Scar Appearance in Breast Surgery
- ClinicalTrials.gov ID
- NCT04554316
- Acronym / sponsor ID
- IRB-2019-118
- Conditions
- Scar, Breast Neoplasms, Breast Diseases, Surgical Wound
- Keywords
- wound healing, cosmesis, postoperative dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parallel placement | Active comparator | Device: Steri-stripSteri-strips will be placed in-line (parallel) with the surgical incision. |
| Perpendicular placement | Active comparator | Device: Steri-stripSteri-strips will be placed perpendicular to the surgical incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steri-stripSteri-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. | Device | Parallel placement, Perpendicular placement |
Primary outcome
Cosmesis score 30 days
Time frame: 30 days
Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 30 days
Cosmesis score 90 days
Time frame: 90 days
Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 90 days
2 secondary outcomes
Surgical site infection
Time frame: 90 days
Wound dehiscence
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background3M 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: PubMed 10491057Katz 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.
- Background: PubMed 4033109Rodeheaver 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.
- Background: PubMed 15108939Pushpakumar 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.
- Individual participant dataSharing planned: No. No plan to share IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candace L Ward, MD, MPH principal investigator
Albert Einstein Medical Center Phialdelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steri-strip in people with Scar and Breast Neoplasms, run by Albert Einstein Healthcare Network at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmesis score 30 days (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04554316, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.