535 Double-blind, Randomized, Controlled Trial Evaluating Early Application of a Surfactant-based Dressing for Partial-thickness Burns (EARLY)
Bibliographic record
Abstract
Abstract Introduction Surfactant-based wound dressings (WSD) have been utilized in chronic, non-healing wounds and small burn wounds to soften and aid removal of wound debris. We conducted a double-blind, randomized controlled study evaluating paired, non-contiguous partial thickness burn wounds comparing WSD versus bacitracin. We hypothesized early application of WSD would lead to less wound conversion and less painful wound care. Methods Sample size was determined based on a projected 25% improvement in salvaged tissue (i.e., excised tissue) with bacitracin as the comparator. Wounds were paired; two non-contiguous partial thickness areas less than 10% TBSA each. Wound care was performed daily, per protocol. Additional outcomes included grafted area, infection, and procedure-associated pain. Patients and assessing surgeons were blinded to treatment assignment. Paired analysis performed for primary outcome and mixed modeling for change in Numeric Pain Rating Scale. SAS 9.4 was used for analysis. Results Patients were consented and treated within 24 hours of injury. All cases were deemed initially necessary for admission. Patients were followed until 95% re-epithelialization occurred or were discharged. Vancouver scar scale was utilized post discharge. Twenty-seven patients were consented. The average time from injury to consent was 14.6 ± 5.6 hours. The average age was 40.9 ± 16.5 years with 65% being male, 50% Black, and 50% Caucasian. Flame injury was most common. The average total body surface area burned was 8.8 ± 3.6%. There was no difference in percent of salvaged tissue, calculated as the amount excised (cm2) relative to the original size of injury [6.1% (95% CI -9.7, 21.9), p=0.4363); 26.9% versus 38.5% of patients had their wounds convert to a deeper injury. However, there was a significant difference [-0.61 (95% CI -1.04, -0.17), p=0.0065) in patient reported pain between treatment assignment (measured at baseline and after each wound care session). There was one wound infection in each group. Conclusions WSD facilitates easier debridement, is resistant to infection without need of antimicrobial exposure, and shows improved patient tolerability. Applicability of Research to Practice WSD is a useful dressing that can be easily applied early after injury and can improve patient’s wound care experience. Funding for the Study Medline funded this study through an investigator-initiated grant, but has not reviewed the results.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.009 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".