NCT06170008

Efficacy of a Transparent Silicone Membrane With Physical Microstructure for Second-degree Burn Wounds and Skin Graft Wounds

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In this study, a single-centre, autologous petrolatum gauze or decellularised pig skin treatment was used to study the effect of physical microstructure-modified transparent silicone membranes on the repair of second-degree burn wounds and implant-area wounds in a parallel controlled study using a randomised controlled clinical trial. In this study, 40 patients were enrolled in the burn surgery department of the First Affiliated Hospital of the Naval Military Medical University, with 20 second-degree burn wounds and 20 implant-area wounds each. The same patients were divided into a conventional treatment group (second-degree burn wounds covered with decellularized pig skin and implant-area wounds covered with petroleum jelly gauze) and a silicone film-covered group according to the computerized random number method. After routine clinical treatment of the wounds, the wounds were covered with the corresponding dressings according to the groups, and the healing rate, transparency of the dressings, adhesion of the dressings to the wounds, pain level of the patients when the dressings were removed, infection rate of the wounds and incidence of adverse reactions were observed.

Conditions

• Second-degree Burn Wounds
• Skin Graft Wounds

Interventions

Type	Name	Description
DEVICE	Physical microstructure-modified transparent silicone film sheet	The 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.
DEVICE	Decellularized pig skin	Decellularized 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.
DEVICE	Vaseline gauze	Vaseline 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.

Timeline

• Start date: 2023-12-30
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2023-12-14
• Last updated: 2023-12-14