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

Naval Military Medical University

Status: Not yet enrolling

Conditions: Second-degree Burn Wounds; Skin Graft Wounds

Treatments: Device: Physical microstructure-modified transparent silicone film sheet; Device: Decellularized pig skin; Device: Vaseline gauze

Study type: Interventional

Funder types: Other

Identifiers

NCT06170008

chhaodylan

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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;
• Traumatic surface infection;
• Involving the face, hands, groin, joints, feet and other areas difficult to bandage and fix; previous burn trauma treatment; previous burns on the same site; electrical burns; patients with inhalation injuries.
• Known sensitivity or allergy to one of the dressings or its components; diabetes mellitus; presence of immune system disorders or long-term hormone or immunotherapy
• Others who, in the opinion of the investigator, are not suitable for enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Second-degree burn wounds covered with silicone film sheet group

Experimental group

Description:

After routine clinical treatment of second-degree burn wounds, the innermost layer is covered with physical microstructure-modified transparent silicone film sheet , and the outer dressing is changed every 3 to 4 days to observe and record the wounds, and the innermost dressing is changed weekly or as necessary and the number of times is recorded to observe the wound healing rate, dressing transparency, dressing-wound adhesion, pain level, wound infection rate and incidence of adverse reactions.

Treatment:

Device: Physical microstructure-modified transparent silicone film sheet

Second-degree burn wounds covered with decellularized pig skin group

Active Comparator group

Description:

After routine clinical treatment of second-degree burn wounds, the innermost layer was covered with decellularized pig skin, the outer dressing was changed every 3 to 4 days, the wounds were observed and recorded, and the innermost dressing was changed weekly or as necessary and the number of times was recorded to observe the wound healing rate, dressing transparency, dressing-wound adhesion, pain level, wound infection rate and incidence of adverse reactions.

Treatment:

Device: Decellularized pig skin

Post-operative skin grafting wounds covered with silicone film sheet group

Experimental group

Description:

After skin grafting, the innermost layer is covered with physical microstructure-modified transparent silicone film sheet , and the outer dressing is changed every 3 to 4 days to observe and record the wound. The innermost layer is changed weekly or as necessary and the number of times is recorded to observe the wound healing rate, transparency of the dressing, adhesion of the dressing to the wound, pain, wound infection rate and incidence of adverse reactions.

Treatment:

Device: Physical microstructure-modified transparent silicone film sheet

Post-operative skin grafting wounds covered with vaseline gauze group

Active Comparator group

Description:

After skin grafting, the innermost layer was covered with vaseline gauze, and the outer layer was changed every 3 to 4 days to observe and record the wound. The innermost layer was changed weekly or as necessary and the number of times was recorded to observe the wound healing rate, transparency of the dressing, adhesion of the dressing to the wound, pain, wound infection rate and incidence of adverse reactions.

Treatment:

Device: Vaseline gauze