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NCT04456127 · ClinicalTrials.gov registry record · NA
CO2 Laser Revision for Burn Related Donor Site Scars
A NA study of Scar and Burn Scar, sponsored by Medstar Health Research Institute.
- Active
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04456127: Active NA study of Scar and Burn Scar, sponsored by Medstar Health Research Institute.
NCT04456127 is a NA study of Scar and Burn Scar that is active but no longer recruiting, run by Medstar Health Research Institute. The registered enrollment target is 25 participants, below the 47-participant average among 15 other Scar trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04456127, a NA study of Scar and Burn Scar, is active but no longer recruiting, sponsored by Medstar Health Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
Scarring from burn wounds remains a chronic and often severe sequela of burn injury. Burn wounds may be left to heal by secondary intention or treated with surgical skin grafting; in both circumstances, significant scars likely result. When surgical skin grafting is employed, skin graft harvest sites ("donor sites") likewise result in clinically significant scars. This study will have interventional and observational components. Patients will receive the standard fractional ablative CO2 treatments to their scars resulting from burn wounds allowed to heal by secondary intention and/or those treated with skin grafts. These will be prospectively observed for the duration of the study as well as adjacent normal skin. In addition, a donor site that meets inclusion criteria that would not have otherwise received LSR will be identified as a treatment site. Patients with have one half of their donor sites randomized to standard of care (SOC) treatment, which consists of wound dressings, compression therapy, physical and occupational therapies and the other half randomized to SOC + ablative fractional CO2 laser therapy (LSR).
Primary Outcome
The primary endpoint will be assessment of control and treatment halves at follow-up evaluation completed 2 months ± 2 weeks after the final laser treatment. The change in scale measure from baseline to date of assessment will be used to compare treatment vs control scar halves. This will be calculated and compared using paired t-test with a p-value of 0.05 as the cutoff for significance.
Conditions Studied
Interventions
- PROCEDURE Fractional CO2 Laser
Study Locations (1)
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-01-21 |
| Est. Completion | 2026-04-12 |
| Phase | NA |
What the registry record for NCT04456127 still lists
NCT04456127 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 47-participant average among 15 other Scar trials with a reported enrollment target (47% lower).
The record links to 3 conditions, with Scar appearing as the primary indexed condition, and to 1 intervention - of which Fractional CO2 Laser is the first listed.
NCT04456127 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT04456127 about?
NCT04456127 is a clinical study titled "CO2 Laser Revision for Burn Related Donor Site Scars". Scarring from burn wounds remains a chronic and often severe sequela of burn injury. Burn wounds may be left to heal by secondary intention or treated with surgical skin grafting; in both circumstances, significant scars likely result. When surgical skin grafting is employed, skin graft harvest site...
What is the current status of trial NCT04456127?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2020-01-21. Estimated completion is 2026-04-12.
What conditions does trial NCT04456127 study?
This clinical trial studies the following conditions: Scar, Burn Scar, Skin Graft Scar.
What interventions are being tested in trial NCT04456127?
The interventions under investigation include: Fractional CO2 Laser (PROCEDURE).
Who is sponsoring clinical trial NCT04456127?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04456127 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Scar
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04456127's enrollment target sits among peer trials
25 13th of 15 higher than 3 of 15 other Scar trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Scar 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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