Status:
NOT_YET_RECRUITING
Efficacy of a Transparent Silicone Membrane With Physical Microstructure for Second-degree Burn Wounds and Skin Graft Wounds
Lead Sponsor:
Changhai Hospital
Conditions:
Second-degree Burn Wounds
Skin Graft Wounds
Eligibility:
All Genders
12-70 years
Phase:
NA
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 gr...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06170008
Start Date
December 30 2023
End Date
December 30 2026
Last Update
December 14 2023
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