Burns scar
Conditions
Interventions
experimental group:Cyclic expansion with a baseline pressure of 10 kPa
experimental group:Cyclic expansion with a baseline pressure of 11 kPa
Sponsors
Burn Department of the First Affiliated Hospital of Army Medical University, PLA
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 60 years old, with no gender restrictions; 2.Patients undergoing skin and soft tissue expander implantation surgery on normal chest skin (including patients requiring flap repair for conditions such as burn scars, cicatricial alopecia, ear and nose reconstruction, giant nevus, and superficial tumors); 3.Study participants shall be enrolled on a voluntary basis and sign "the Informed Consent Form";
Exclusion criteria
Exclusion criteria: Patients with definite non - superficial malignant tumors, acquired immunodeficiency syndrome (AIDS), diabetes mellitus, autoimmune diseases, or a history of organ transplantation. Pregnant or lactating patients. Patients who have experienced myocardial infarction or cerebrovascular accident within 6 months. Patients with underlying diseases including hypertension, diabetes mellitus, rheumatic diseases, and peripheral vascular - related disorders. Patients with a history of radiotherapy in the skin area to be expanded. Patients with coagulation disorders or severe bleeding tendency that cannot be corrected before surgery. Patients who, as comprehensively evaluated by the researchers, are unable to comply with the operation and usage precautions of the cyclic tissue expander and are deemed unsuitable for enrollment. Patients who have undergone radical resection of superficial malignant tumors for less than one year or have recurrent tumors. Patients with poor compliance who are unable to complete the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of serious adverse events (SAE) during the expansion process; | — |
Secondary
| Measure | Time frame |
|---|---|
| Expansion index (EI) at 3 months of expansion;injection volume;skin condition;transcutaneous oxygen tension;skin blood perfusion; | — |
Countries
China
Contacts
Public ContactZhan Rixing
the First Affiliated Hospital of Army Medical University
Outcome results
None listed