Ignite Creation Date:
2024-05-06 @ 5:48 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05439746
Status:
UNKNOWN
Last Update Posted:
2022-10-28
First Post:
2022-06-01
Brief Title:
A Study to Evaluate the Efficacy of Microlyte Matrix in the Management of Donor Site Wounds
Sponsor:
Imbed Biosciences
Organization:
Imbed Biosciences
Study Overview
Official Title:
Clinical Trial to Assess the Efficacy of Microlyte Matrix on the Healing of Surgically Created Partial Thickness Donor Site Wounds on Patients Requiring Split-thickness Skin Grafting
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
NOT_YET_RECRUITING
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:
A study to to evaluate the efficacy of Microlyte Matrix by demonstrating its superiority to the standard of care in the healing of donor site wounds in patients requiring split-thickness grafting as well as to assess the occurrence of donor site wound infection allergic reaction pain and itching and scarring at 12 weeks assessed by patients using the Patient and Observer Scar Assessment Scale POSAS
Detailed Description:
The proposed study is a randomized controlled open-label clinical trial to assess the efficacy in wound healing of the FDA 510k cleared Microlyte Matrix K153756 in surgically created partial thickness donor site wounds 100 cm2 in size on patients and harvested at 121000th inch requiring split-thickness skin grafting Subjects are expected to be hospitalized as in-patients for approximately 7 days following initial donor site surgery Study visits conducted after hospital discharge must be conducted as out-patient clinic visits
Each wound will be divided into proximal and distal halves with one half randomized to receive Microlyte Matrix KaltostatTegaderm will be used as the control Thus each patient is their own control removing the potential variability of the depth of donor site wounds between patients as a confounding factor
Microlyte Matrix is a FDA-cleared K153756 antimicrobial dressing manufactured by Imbed Biosciences Inc Madison WI which is an ISO 13485 certifiedFDA QSR compliant facility It is indicated for the management of partial and full thickness wounds including pressure ulcers venous stasis ulcers diabetic foot ulcers first and second-degree burns abrasions and lacerations donor sites and surgical wounds
Each wound will be divided into proximal and distal halves with one half randomized to receive Microlyte Matrix KaltostatTegaderm will be used as the control Thus each patient is their own control removing the potential variability of the depth of donor site wounds between patients as a confounding factor
Microlyte Matrix is a FDA-cleared K153756 antimicrobial dressing manufactured by Imbed Biosciences Inc Madison WI which is an ISO 13485 certifiedFDA QSR compliant facility It is indicated for the management of partial and full thickness wounds including pressure ulcers venous stasis ulcers diabetic foot ulcers first and second-degree burns abrasions and lacerations donor sites and surgical wounds
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?:
True
Is an FDA AA801 Violation?:
None