The goal of this clinical trial is to comparison of physical microstructure-modified transparent silicone films and current conventional trauma dressings for second-degree burn wounds and post-skin graft wounds.The main question it aims to answer is :
The development of a new type of wound dressing is urgently needed because existing wound dressings cannot be transparent, easy to change, easy to store and inexpensive at the same time.
Participants will receive routine wound treatment, after which they will be covered with a clear silicone membrane with physical microstructure modification.
Researchers will compare vaseline gauze group and decellularised pigskin group o see if transparent silicone film with physical microstructure modifications promotes wound healing, reduces the number of dressing changes, reduces the damage to the wound and painful irritation to the patient during dressing changes, thus improving the quality of wound repair and saving medical costs.
Age 12 to 70 years, regardless of gender;
Second-degree burns with an area greater than 1% TBSA and a single observable trauma area ≥ 10 cm × 10 cm(jointly determined by two burn specialists with the title of attending physician or above according to the four degrees and five points method);
Voluntary signed informed consent form
Patients during pregnancy;
Significant cardiac, pulmonary and renal insufficiency;
Critically ill or with serious complications such as severe sepsis or MODS;
Positive for HBV, HCV, HIV or syphilis;
Parallel
Physical microstructure-modified transparent silicone film sheet
DeviceThe main component of the physical microstructure-modified transparent silicone film sheet is transparent silicone rubber, which has a three-dimensional microstructure on its trauma contact surface through physical mechanics treatment, which can provide effective mechanical stimulation for trauma healing. And after testing, the silicone film sheet is breathable, light-permeable, non-toxic and non-allergenic. It is expected to significantly reduce the number of dressing changes, reduce the damage to the wound and the painful stimulation to the patient during dressing changes, and promote the healing of the wound to a certain extent, thus improving the quality of wound repair and saving medical costs.
Decellularized pig skin
DeviceDecellularized pig skin is an allogeneic trauma covering from pigs and is a commonly used trauma covering for second-degree burn wounds. It adheres to clean superficial wounds, creates a temporary barrier to the wound, reduces wound exudation, limits loss of body components, improves microcirculatory stasis, provides a microenvironment suitable for wound healing, protects inter-ecological tissue, promotes repair and regeneration, and reduces pain. Its disadvantages are: soft structure, difficult to fix the trauma; opaque, unable to observe the trauma; pigskin needs to be stored under suitable temperature and humidity, and has a limited time. When used, decellularized pig skin is directly covered on conventionally treated second-degree burn wounds.
Vaseline gauze
DeviceVaseline gauze is the most commonly used conventional dressing for the implant area, which is mainly made of skimmed cotton gauze impregnated with petroleum jelly and paraffin oil, which has a lubricating effect and can promote the growth of granulation and wound healing. However, its moisturizing time is relatively short and requires frequent dressing changes; moreover, petroleum jelly gauze often adheres to the wound surface severely, which may cause bleeding and new epidermal damage during dressing changes and affect the wound healing; the wound surface is constantly oozing blood and fluid, and the dressing cannot be effectively isolated from the outside world after wetting, which increases the chance of infection. Vaseline gauze is applied directly to the post-operative skin grafting wound.
Wound healing time
Change the dressing at one-day intervals after the application of trauma coverings, observe the trauma, and record the healing time when the trauma is 90% healed. The wound healing rate is: healed wound area / original wound area. There are two methods to calculate the healed area: A, visual method: visual assessment; B, image analysis method: vertical trauma surface is photographed under natural light (20CM and 40CM respectively), and the computer analyzes the trauma healing rate. The image analysis method shall prevail, and the image method shall prevail in case of inconsistent results.
Wound healing rate
The wound healing rate was calculated on the 14th days after the treatment. The wound healing rate was calculated as: healed wound area/ original wound area. There are two methods for calculating the healed area: A, visual method: visual assessment; B, image analysis method: vertical trauma surface is photographed under natural light (20CM and 40CM distance respectively) and the computer analyzes the trauma healing rate. The image analysis method shall prevail, and the image method shall prevail in case of inconsistent results.
Transparency
The transparency of the inner dressing was evaluated at days 7, 14 after wound treatment. They were: clear, the trabecular base could be observed (including fluid infection, survival of trabecular new epithelium or graft, etc.); obscure, the trabecular base was faintly visible; opaque, the trabecular base could not be observed.
Adhesions and pain
Observe the degree of adhesion and patient pain when changing the inner dressing. Scoring using the "Changhai Pain Ruler", with 0 indicating no pain; 1\~3 indicating slight pain, tolerable; 4\~6 indicating obvious pain and affecting sleep, still tolerable; 7\~10 indicating strong pain, affecting appetite for sleep, unbearable.
Number of inner layer dressing changes
Record the number of inner dressing changes during the wound healing process.
Infection rate
Wound infection was observed at 7, 14, 21, and 28 days after transplantation, respectively.Observation of trauma infection: amount and nature of trauma secretion, odor; peri-trauma skin temperature and presence of redness, swelling and pressure pain. Bacterial culture of trauma secretions: Bacterial culture of secretions was performed at 7, 14 and 21 days after transplantation.
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