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

Not Applicable

Completed

Interventions: Device: Sidaiyi® wound dressing
Device: HQ® Matrix Medical Wound Dressing

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Sidaiyi® wound dressing	Sidaiyi® wound dressing	After harvesting the graft, the donor site wounds were treated with the dressing material. Dressing changes if needed.
HQ® Matrix Medical Wound Dressing	HQ® Matrix Medical Wound Dressing	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.

Primary Outcome Measures

Name	Time	Method
Time to Wound Healing	Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Growth of Granulation Tissue	Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation	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.
Number of Participants With Inflammatory Reaction	Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation	Physician assessment determined presence of inflammatory reaction which is characterized by pain, heat, redness and swelling.
Pain Perceived by Patient	Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation	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).
Number of Participants With Exudation	Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation	Physician assessment determined presence of exudation by observing whether the gauze over the primary wound dressings was soaked by exudation: 1. Less than two gauze was soaked by exudation within 24h---No exudation (-); 2. Two to four gauze was soaked by exudation within 24h---Little exudation (+); 3. More than four gauze was soaked by exudation within 24h---Much exudation (++);

Locations (2): The Second Xiangya Hospital of Central South University
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Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
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Changsha, Hunan, China