Evaluation of HQ® Matrix Medical Wound Dressing for Healing of Donor Site Wounds

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the safety and effectiveness of HQ® Matrix Medical Wound Dressing for repair of donor site wounds. Half of participants will receive HQ® Matrix Medical Wound Dressing, while the other half will receive Sidaiyi® wound dressing.

Detailed Description
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HQ® Matrix Medical Wound Dressing is a transparent, non-porous, pliable, gas-permeable, and waterproof film dressing which is comprised of silk fibroin protein of the Bombyx mori (B. mori) silkworm. It is intended to provide a moist, gas-permeable and sterile environment to facilitate the normal wound healing process. It is used in the management of non-infected skin defects and various dermal wounds. Sidaiyi® wound dressing (Suzhou Soho Biomaterial Science and Technology Co., Ltd, Suzhou, China) is a CFDA approved (Su2012-2640182), silk fibroin-based, two-layered spongy dressing. Upon the silk fibroin spongy dressing layer is a membrane made of medical silicone. It is used in the management of partial- and full-thickness wounds, donor site wounds and burns. Currently, it is the sole silk fibroin biomaterial for wound healing that has received regulatory approval worldwide.

Official Title
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Randomized, Active-controlled, Single-blind, Parallel Two-group Trial of HQ® Matrix Medical Wound Dressing and Sidaiyi® Wound Dressing for the Treatment of Donor Site Wounds

Conditions
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Donor Site Wound

Intervention / Treatment
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* Device: HQ® Matrix Medical Wound Dressing
* Device: Sidaiyi® wound dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients, aged from 18 - 60, male or female, with wet wounds or burns, ulcerative skin and soft tissue wound surfaces; The wound surface area ranged from 20cm^2 to 600cm^2; The patients had a clear mind and there was no misunderstanding; The patients voluntarily signed the subjects' informed consent form and received timely follow-ups. Exclusion Criteria: Patients with active bleeding in wound surfaces; Vasogenic diseases: patients with no blood supply or phlebothrombosis in local wound tissues; Those allergic to silk materials; Those with serious infection; Those with coagulation disorders; Those with tumors or diabetes; Patients who, according to other doctors' opinion, are unsuitable to use this material for wound treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HQ® Matrix Medical Wound Dressing<br>After harvesting the graft, the donor site wounds were treated with the dressing material. Dressing changes if needed. An operative removal of the HQ® Matrix Medical Wound Dressing is not required as it becomes spontaneously detached from the regenerated skin areas. | Device: HQ® Matrix Medical Wound Dressing<br> <br> * Other names: HQ® Matrix;|
| Active Comparator: Sidaiyi® wound dressing<br>After harvesting the graft, the donor site wounds were treated with the dressing material. Dressing changes if needed. | Device: Sidaiyi® wound dressing<br> <br> * Other names: Sidaiyi®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Wound Healing | Healing time was recorded when complete re-epithelialization had occurred. If the wound healed in advance, visit until the wound was completely healed. If the wounds were unable to heal for more than 21±3 days, unanticipated follow-ups were added until the wound was completely healed. | Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Growth of Granulation Tissue | Physician assessment of tissue with healthy granulation tissue defined as is granular and uneven in texture, does not bleed easily and is pink in color. Unhealthy granulation tissue is typically dark which can be indicative of poor perfusion, ischemia and/or infection. | Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation | 
| Number of Participants With Inflammatory Reaction | Physician assessment determined presence of inflammatory reaction which is characterized by pain, heat, redness and swelling. | Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation | 
| Pain Perceived by Patient | The amount of pain that a patient perceived was assessed using a Visual Analogue Scale (VAS 0-10), which ranges across a continuum from 0 (no pain) to 10 (worst pain). | Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation | 
| Number of Participants With Exudation | Physician assessment determined presence of exudation by observing whether the gauze over the primary wound dressings was soaked by exudation: Less than two gauze was soaked by exudation within 24h---No exudation (-); Two to four gauze was soaked by exudation within 24h---Little exudation (+); More than four gauze was soaked by exudation within 24h---Much exudation (++); | Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation |