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NCT05028816 · ClinicalTrials.gov registry record · NA
Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction
A NA study of Surgical Incision, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT05028816: Completed NA study of Surgical Incision, sponsored by University of Texas Southwestern Medical Center.
NCT05028816 is a NA study of Surgical Incision that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 39 participants, below the 150-participant average among 3 other Surgical Incision trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05028816, a NA study of Surgical Incision, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective, within-subject randomized, single blinded study designed to follow up to forty-two (42) qualified and consenting adult females, 18-65 years of age scheduled for elective breast reduction surgery using a standard inverted Wise (inverted "T") incision pattern
Primary Outcome
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 t
Conditions Studied
Interventions
- DEVICE Side 1: Final layer closure with force modulating tissue bridges (FMTB)
- OTHER Side 1: Final layer dermal closure with poliglecaprone 25 suture
- DEVICE Side 2: Final layer closure with force modulating tissue bridges (FMTB)
- OTHER Side 2: Final layer dermal closure with poliglecaprone 25 suture
Study Locations (1)
Texas
- UT Southwestern Medical Center- Outpatient Building - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2021-10-05 |
| Est. Completion | 2024-12-01 |
| Phase | NA |
What the finished NCT05028816 record still lists
NCT05028816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 150-participant average among 3 other Surgical Incision trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Surgical Incision appearing as the primary indexed condition, and to 4 interventions - of which Side 1: Final layer closure with force modulating tissue bridges (FMTB) is the first listed.
NCT05028816 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05028816 about?
NCT05028816 is a clinical study titled "Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction". This is a prospective, within-subject randomized, single blinded study designed to follow up to forty-two (42) qualified and consenting adult females, 18-65 years of age scheduled for elective breast reduction surgery using a standard inverted Wise (inverted "T") incision pattern
What is the current status of trial NCT05028816?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2021-10-05. Estimated completion is 2024-12-01.
What conditions does trial NCT05028816 study?
This clinical trial studies the following conditions: Surgical Incision.
What interventions are being tested in trial NCT05028816?
The interventions under investigation include: Side 1: Final layer closure with force modulating tissue bridges (FMTB) (DEVICE), Side 1: Final layer dermal closure with poliglecaprone 25 suture (OTHER), Side 2: Final layer closure with force modulating tissue bridges (FMTB) (DEVICE), Side 2: Final layer dermal closure with poliglecaprone 25 suture (OTHER).
Who is sponsoring clinical trial NCT05028816?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05028816 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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