Burn
Conditions
Interventions
Trial Group:Novel non-pharmacological electrical signal analgesic device (single-use sterile dressing) directly applied to the donor site wound and sealed.
Control Group:Self-adhesive soft silicone foam dressing Mepilex directly applied to the donor site wound, combined with intravenous flurbiprofen axetil (loading dose: 50mg slow IV push
maintenance dose: 100mg every 12 hours IV infusion).
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Donor site area for burn skin grafting is less than 20% of total body surface area (TBSA); 2. Presence of pain at the donor site following burn skin grafting, with a Visual Analog Scale (VAS) pain score or Numeric Rating Scale (NRS) score >= 5; 3. Age between 18 and 65 years, inclusive, regardless of gender; 4. Body mass index (BMI) between 18.5 and 27.9; 5. The patient or authorized representative has been informed of the study and has provided a signed and dated informed consent form; 6. Commitment to comply with the study procedures and cooperate throughout the full course of the study;
Exclusion criteria
Exclusion criteria: 1. Occurrence of severe adverse drug reactions; 2. Concomitant use of psychotropic or sedative medications known to affect pain perception; 3. History of psychiatric illness or altered consciousness rendering the patient unable to cooperate; 4. Presence of severe organ dysfunction (e.g., cardiovascular or cerebrovascular accident within the preceding 3 months, malignancy, severe hepatic or renal insufficiency); 5. Extensive burns complicated by severe infection or shock; presence of inhalation injury requiring tracheotomy and mechanical ventilation; 6. American Society of Anesthesiologists (ASA) Physical Status classification of Grade IV or inability to survive beyond 24 hours despite treatment; 7. Refusal by the patient or authorized representative to sign the informed consent form;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in resting pain NRS score;Change from baseline in procedural pain NRS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to achieve a decrease of more than 2 points in VAS pain score from baseline across groups;Percentage change in pain intensity (SPID24 and SPID48);Healing time of donor site (time to 95% re-epithelialization);Incidence rate of drug-related adverse reactions (nausea, vomiting, gastrointestinal bleeding, dizziness, somnolence);Degree of reduction in inflammatory cytokine concentrations (TNF-a, IL-1ß) in wound exudate at donor site; | — |
Countries
China
Contacts
Public ContactLiu Yan
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed