Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143683
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-16
Brief Title:
Early Versus Late Upper Extremity Mobilization After Meshed Sheet Split Thickness Skin Autograft on Wound Healing in Adult Burn Patients
Sponsor:
Hamilton Health Sciences Corporation
Organization:
Hamilton Health Sciences Corporation
Study Overview
Official Title:
The Impact of Early Versus Late Upper Extremity Mobilization After Meshed Sheet Split Thickness Skin Autograft on Wound Healing in Adult Burn Patients - A Single Center Non-Inferiority Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
EXTREMA
Brief Summary:
STSGs are used to close wounds and minimize infections After receiving a meshed or sheet split-thickness skin graft STSG to the upper extremity or hand for a thermal burn injury burn surgeons use different methods to improve graft take and reduce complications This includes different start dates and times for activity
The goal of this clinical trial is to provide more evidence to improve rehabilitation procedures after STSG operations for patients with burn injuries The main questions it aims to answer are
To determine if early mobilization is non-inferior to late mobilization of the upper extremity after meshed STSG with regards to wound healing in adult burn patients
To determine if early mobilization is non-inferior to late mobilization of the upper extremity after sheet STSG with regards to wound healing in adult burn patients
Participants will be assigned randomly like flipping a coin to one of two groups early mobilization and late mobilization Mobilization is the range of motion exercises performed under the supervision of the physical therapy team Researchers will compare early and late mobilization to see if there are differences in wound healing range of motion local and systemic complications and discharge outcomes
Participants will be asked to
Early mobilization group begin mobilization of their upper extremity one day after their STSG operation If their burn includes a graft to your hand early mobilization of this area will begin three days after their STSG operation
Late mobilization group elevate their elbow in a splint to limit movement until five days after their operation and begin mobilization five days after their STSG operation
The goal of this clinical trial is to provide more evidence to improve rehabilitation procedures after STSG operations for patients with burn injuries The main questions it aims to answer are
To determine if early mobilization is non-inferior to late mobilization of the upper extremity after meshed STSG with regards to wound healing in adult burn patients
To determine if early mobilization is non-inferior to late mobilization of the upper extremity after sheet STSG with regards to wound healing in adult burn patients
Participants will be assigned randomly like flipping a coin to one of two groups early mobilization and late mobilization Mobilization is the range of motion exercises performed under the supervision of the physical therapy team Researchers will compare early and late mobilization to see if there are differences in wound healing range of motion local and systemic complications and discharge outcomes
Participants will be asked to
Early mobilization group begin mobilization of their upper extremity one day after their STSG operation If their burn includes a graft to your hand early mobilization of this area will begin three days after their STSG operation
Late mobilization group elevate their elbow in a splint to limit movement until five days after their operation and begin mobilization five days after their STSG operation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None