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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HQ® Matrix Medical Wound Dressing | Experimental | 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. |
|
| Sidaiyi® wound dressing | Active Comparator | After harvesting the graft, the donor site wounds were treated with the dressing material. Dressing changes if needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HQ® Matrix Medical Wound Dressing | Device |
|
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Qian, PhD | Second Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China | ||
| The Third Xiangya Hospital of Central South University |
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| ID | Title | Description |
|---|---|---|
| FG000 | HQ® Matrix Medical Wound Dressing | Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed HQ® Matrix Medical Wound Dressing |
| FG001 | Sidaiyi® Wound Dressing | Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed Sidaiyi® wound dressing |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | HQ® Matrix Medical Wound Dressing | Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed HQ® Matrix Medical Wound Dressing |
| BG001 | Sidaiyi® Wound Dressing |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Posted | Number | participants | Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HQ® Matrix Medical Wound Dressing | Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed HQ® Matrix Medical Wound Dressing |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Empyema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Li Qian | The Second Xiangya Hospital of Central South University | +86-13958104032 | 649418291@qq.com |
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| Sidaiyi® wound dressing |
| Device |
|
|
| 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:
| Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation |
| Changsha |
| Hunan |
| 410013 |
| China |
Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
Sidaiyi® wound dressing
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Number of Participants With Inflammatory Reaction | Physician assessment determined presence of inflammatory reaction which is characterized by pain, heat, redness and swelling. | Posted | Number | participants | Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation |
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| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation |
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| Secondary | 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:
| Posted | Number | participants | Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation |
|
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| Primary | 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. | Posted | Mean | Standard Deviation | Days | Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation |
|
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Sidaiyi® Wound Dressing | Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed Sidaiyi® wound dressing | 0 | 35 | 4 | 35 |
| Excessive fluid leakage with odors | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Much exudation (++) |
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