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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
71
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
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.
Time frame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
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.
Time frame: 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.
Time frame: 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).
Time frame: 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: 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 (++);
Time frame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.