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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-70
SponsorChanghai Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Physical microstructure-modified transparent silicone film sheet
  • Decellularized pig skin
  • Vaseline gauze

Treatment groups

40 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators