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Closed Burn Wound Dressing Using a Hydrofiber with Silver to Minimize Pain and Increase Satisfaction: A Prospective, Multicentered, Double-blinded, Randomized Controlled Trial

Phase 3
Conditions
Superficial second&#45
degree burn.
Burns
Assessment
Hydrofiber
Pain
Silver
Registration Number
TCTR20201028005
Lead Sponsor
one
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending (Not yet recruiting)
Sex
All
Target Recruitment
40
Inclusion Criteria

The inclusion criteria were the patients with superficial second-degree burn wounds on the trunk or extremities. The superficial second degree was defined as the wounds that were erythema, tender, and could contain blisters. The etiology must be scald or flamed burn. The time of injury was within 48 hours to reduce the risk of infection.17 The total body surface area did not exceed 30% to prevent the chance of immunosuppression.18,19 Included patients were over seven years of age and were haemodynamically stable (mean arterial pressure ≥ 65 mmHg, urine output of 0.5-1 mL/kg/h, and adequate conscious to answer the pain number rating scale). Written or fingerprint informed consent was obtained from all participants.

Exclusion Criteria

The exclusion criteria were the wound that contained other types of burn wounds such as deep second degree, third degree, and indeterminate burn. The wounds within 15 cm around the perianal and genital area were excluded because of the chance of fecal or urine contamination. Heavily contaminated wounds and the patients with pregnancy, bleeding tendency, diabetes mellitus, or psychiatric disorder were also excluded.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Worst pain score 1 day Numerical rating scale
Secondary Outcome Measures
NameTimeMethod
Procedural pain score 1 day Numerical rating scale,number of dressing changes 1 day Counting each time the dressing is changed.,Morphine consumption 14 days Retrieving from the nurse note,satisfaction score 1 day Visual analogue scale,complete wound closure 1 day Expert assessment,wound infection 1 day Expert assessment
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