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NCT04554316 · ClinicalTrials.gov registry record · NA
Aesthetic Effect of Steri-Strip Orientation on Healing and Scar Appearance in Breast Surgery
A NA study, sponsored by Albert Einstein Healthcare Network.
- Completed
- Registry status
- NA
- Development phase
- 94
- Enrollment target
NCT04554316: Completed NA study, sponsored by Albert Einstein Healthcare Network.
NCT04554316 is a NA study that has completed, run by Albert Einstein Healthcare Network. The registered enrollment target is 94 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04554316, a NA study, has completed, sponsored by Albert Einstein Healthcare Network.
- COMPLETED
- Registry status
- NA
- Development phase
- 94 participants
- Enrollment target
Study 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.
Primary Outcome
Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 30 days
Interventions
- DEVICE Steri-strip
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2020-11-01 |
| Est. Completion | 2023-07-15 |
| Phase | NA |
What the finished NCT04554316 record still lists
NCT04554316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Steri-strip is the first listed.
NCT04554316 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04554316 about?
NCT04554316 is a clinical study titled "Aesthetic Effect of Steri-Strip Orientation on Healing and Scar Appearance in Breast Surgery". 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 alle...
What is the current status of trial NCT04554316?
This trial is currently completed. It is a NA study. The enrollment target is 94 participants. The study started on 2020-11-01. Estimated completion is 2023-07-15.
What interventions are being tested in trial NCT04554316?
The interventions under investigation include: Steri-strip (DEVICE).
Who is sponsoring clinical trial NCT04554316?
This trial is sponsored by Albert Einstein Healthcare Network, which has 48 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04554316's enrollment target sits among peer trials
94 935th of 2000 higher than 1,064 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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