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

Overview

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.

Interventions

• 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
• 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
• 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 dr

Primary outcome measures

• Wound healing time [Time frame: one day interval after wound coverage application]
• Wound healing rate [Time frame: 14th days after the treatment]

Secondary outcome measures (5)

• Transparency [Time frame: 7th, 14th, 21st and 28th days after the treatment]
• Adhesions and pain [Time frame: 7th, 14th, 21st and 28th days after the treatment]
• Number of inner layer dressing changes [Time frame: Within four weeks of treatment]
• Infection rate [Time frame: 7th, 14th, 21st and 28th days after the treatment]
• Incidence of adverse reactions [Time frame: 7th, 14th, 21st and 28th days after the treatment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06170008 · chhaodylan

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗