NCT05439746

A Study to Evaluate the Efficacy of Microlyte Matrix in the Management of Donor Site Wounds

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Imbed Biosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 12/1000th 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. Kaltostat/Tegaderm 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 certified/FDA 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.

Conditions

• Wounds and Injuries

Interventions

Type	Name	Description
DEVICE	Microlyte® Matrix	Microlyte® Matrix is indicated for the management of wounds and can be used over-the-counter for minor wounds such as abrasions and lacerations, minor cuts, and minor scalds and burns. Under the direction of a healthcare professional, Microlyte® Matrix may be used for more serious wounds such as partial and full thickness pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree burns, abrasions and lacerations, donor sites and surgical wounds. Microlyte® Matrix may be used over debrided and grafted partial thickness wounds.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-01-30
• Completion: 2024-01-30
• First posted: 2022-06-30
• Last updated: 2022-10-28

Regulatory

• FDA-regulated device study