Ignite Creation Date:
2024-05-06 @ 2:53 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04456127
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2020-06-23
Brief Title:
CO2 Laser Revision for Burn Related Donor Site Scars
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Ablative Fractional CO2 Laser Revision for Burn Related Donor Site Scars A Pilot Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None