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no bugdet for the study
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PRF Based Dressing Versus AQUACEL® for Local Treatment of Skin Graft Donor Site: A Non-Inferiority Trial
A prospective single-blind study, where the evaluator is blinded to the treatment. Each patient will be dressed with both Aquacel® and PRF dressing. Half of the donor site area will be dressed with PRF dressing, and half with Aquacel®.
3 days after surgery the patients will be asked to complete a VAS questionnaire. A week and 2 weeks after surgery, patients will have their dressing changed as in the first treatment, and will answer VAS(9) and bluebelle(10) questionnaires. The wound will be photographed again for follow-up. Three weeks, 6 weeks and 3 months after surgery the scar in the donor area will be evaluated. The photographs will be shown to the blinded evaluator, to evaluate wound healing by epithelialization estimation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospitalized burn patients | Experimental | Half of the donor site area will be dressed with PRF dressing, and half with Aquacel®. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Half of the harvested area will be dressed with PRF dressing, and half with Aquacel®. | Other | Half of the harvested area will be dressed with PRF dressing, and half with Aquacel®. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of percentage of wound healing after 1 week, 2 weeks and 3 weeks. | Primary variables will be analyzed using ImageJ software. | 3 weeks |
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Inclusion Criteria:
- Patients with a small burn (2-20% TBSA), who require skin grafting.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam health care campus | Haifa | 3525408 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. Peck MD. Epidemiology of burns throughout the world. Part I: Distribution and risk factors. Vol. 37, Burns. Burns; 2011. p. 1087-100. 2. Lee RC, Teven CM. Acute Management of Burn/Electrical Injuries. In: Song DH, editor. Neligen's Plastic Surgery. 4th ed. Elsevier Ltd; 2018. p. 391-423. 3. Ding X, Shi L, Liu C, et al. A randomized comparison study of Aquacel Ag and Alginate Silver as skin graft donor site dressings. Burns. 2013 Dec;39(8):1547-50. 4. Haith LR, Stair Buchmann ME, Ackerman BH, et al. Evaluation of Aquacel Ag for Autogenous Skin Donor Sites. J Burn Care Res. . Nov-Dec 2015;36(6):602-6. 5. Sousa F, Machado V, Botelho J, Proença L, Mendes JJ, Alves R. Effect of A-PRF Application on Palatal Wound Healing after Free Gingival Graft Harvesting: A Prospective Randomized Study. Eur J Dent [Internet]. 2020 Feb 1 [cited 2020 Sep 20];14(1):63-9. Available from: https://pubmed.ncbi.nlm.nih.gov/32168533/ 6. Chou TM, Chang HP, Wang JC. Autologous platelet concentrates in maxillofacial regenerative therapy [Internet]. Vol. 36, Kaohsiung Journal of Medical Sciences. John Wiley and Sons Inc.; 2020 [cited 2020 Sep 20]. p. 305-10. Available from: https://pubmed.ncbi.nlm.nih.gov/32052598/ 7. Somani A, Rai R. Comparison of efficacy of autologous platelet-rich fibrin versus saline dressing in chronic venous leg ulcers: A randomised controlled trial. J Cutan Aesthet Surg [Internet]. 2017 Jan 1 [cited 2020 Sep 20];10(1):8-12. Available from: https://pubmed.ncbi.nlm.nih.gov/28529414/ 8. Wang L, Liu G, Li Z, Jia BC, Wang Y. Clinical application of platelet-rich fibrin in chronic wounds combined with subcutaneous stalking sinus. Zhonghua Shao Shang Za Zhi [Internet]. 2018 Sep 20 [cited 2020 Sep 20];34(9):637-42. Available from: https://pubmed.ncbi.nlm.nih.gov/30293368/ 9. Piccin A, Di Pierro AM, Canzian L, Primerano M, Corvetta D, Negri G, et al. Platelet gel: A new therapeutic tool with great potential [Internet]. Vol. 15, Blood Transfusion. SIMTI Servizi Sri; 2017 [cited 2020 Sep 20]. p. 333-40. Available from: https://pubmed.ncbi.nlm.nih.gov/27483482/ 10. Ding Y, Cui L, Zhao Q, et al. Platelet-Rich Fibrin Accelerates Skin Wound Healing in Diabetic Mice. Ann Plast Surg. 2017 Sep;79(3):e15-e19. 11. Yüce E, Kömerik N. Potential effects of advanced platelet rich fibrin as a wound-healing accelerator in the management of alveolar osteitis: A randomized clinical trial. Niger J Clin Pract. 2019 Sep;22(9):1189-1195. 12. Alpan AL, Cin GT. PRF improves wound healing and postoperative discomfort after harvesting subepithelial connective tissue graft from palate: a randomized controlled trial. Clin Oral Investig. 2020 Jan;24(1):425-436. 13. Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA. Studies with pain rating scales. Ann Rheum Dis [Internet]. 1978 [cited 2020 Sep 20];37(4):378-81. Available from: https://pubmed.ncbi.nlm.nih.gov/686873/ 14. Macefield R, Blazeby J, Reeves B, Brookes S, Avery K, Rogers C, et al. Validation of the Bluebelle Wound Healing Questionnaire for assessment of surgical-site infection in closed primary wounds after hospital discharge. BJS [Internet]. 2019 Feb 17 [cited 2020 Sep 20];106(3):226-35. Available from: https://onlinelibrary.wiley.com/doi/abs/10.1002/bjs.11008 |
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| ID | Term |
|---|---|
| D002266 | Carboxymethylcellulose Sodium |
| ID | Term |
|---|---|
| D008747 | Methylcellulose |
| D002482 | Cellulose |
| D005936 | Glucans |
| D011134 | Polysaccharides |
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A prospective single-blind study, where the evaluator is blinded to the treatment. Each patient will be dressed with both Aquacel® and PRF dressing. Half of the donor site area will be dressed with PRF dressing, and half with Aquacel®.
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Each patient will be dressed with both Aquacel® and PRF dressing. Half of the donor site area will be dressed with PRF dressing, and half with Aquacel®.
3 days after surgery the patients will be asked to complete a VAS questionnaire. A week and 2 weeks after surgery, patients will have their dressing changed as in the first treatment, and will answer VAS(9) and bluebelle(10) questionnaires. The wound will be photographed again for follow-up. Three weeks, 6 weeks and 3 months after surgery the scar in the donor area will be evaluated. The photographs will be shown to the blinded evaluator, to evaluate wound healing by epithelialization estimation.
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| D002241 |
| Carbohydrates |