Clinical trial NCT06170008: Efficacy of a Transparent Silicone Membrane With Physical Microstructure for Second-degree Burn Wounds and Skin Graft Wounds
Official title: Efficacy of a Transparent Silicone Membrane With Physical Microstructure for Second-degree Burn Wounds and Skin Graft Wounds
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Second-degree Burn Wounds
Skin Graft Wounds
Keywords: Second-degree burn wounds
skin graft wounds
Wound coverings
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The second-degree burn wounds were covered with clear silicone film and decellularized pig skin after conventional clinical treatment.

After skin grafting, the wounds were covered with transparent silicone film and petroleum jelly gauze with physical microstructure modification.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Wound healing time
timeFrame: one day interval after wound coverage application
measure: Wound healing rate
timeFrame: 14th days after the treatment
Secondary outcomes:
measure: Transparency
timeFrame: 7th, 14th, 21st and 28th days after the treatment
measure: Adhesions and pain
timeFrame: 7th, 14th, 21st and 28th days after the treatment
measure: Number of inner layer dressing changes
timeFrame: Within four weeks of treatment
measure: Infection rate
timeFrame: 7th, 14th, 21st and 28th days after the treatment
measure: Incidence of adverse reactions
timeFrame: 7th, 14th, 21st and 28th days after the treatment
Other outcomes:
Locations:
Study officials:
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