Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
»
2024
INTERVENTION: The researchers will conduct a double‐blind clinical trial during which neither the assessor of completeness of donor site wound epithelialization nor the patient will be informed of the nature of the primary dressing used. After getting the patients consent for the study and the operation the patient will be randomly allocated to the control or experimental group. Using the online ResearchRanzomizer application 122 numbers (from 1 to 122) were randomly distributed into two groups comprising 61 numbers each, group 1 (control) and group 2 (experimental). Group 1: 79,11, 26, 88, 92, 25, 12, 104, 32, 118, 47, 29, 18, 109, 28, 101, 87, 111, 115, 78,66, 37,83, 52, 40, 72, 1, 34, 14, 77, 21, 6, 58, 108, 50, 75, 56, 19, 84, 113, 97,96, 67, 45, 85, 16, 99, 93, 8, 31, 3, 120, 107,43, 54, 10, 53,65, 42, 2, 81. Group 2 : 4, 17, 7, 22, 27, 39, 30, 5, 105, 116, 41, 48, 63, 36, 15, 76, 38, 62, 102, 46, 49, 60, 117, 44, 86, 82, 59, 70, 61, 24, 64, 89, 122, 55, 90, 20, 100, 112, 119, 121, 57, 114, 13, 51, 103, 98, 106, 68, 23, 71, 73, 95,35, 94, 9, 80, 91, 110, 33, 69, 74. For each new patient meeting the study selection criteria, a draw will be made by a nurse from a bo Xcontaining 122 numbers (from 1 to 122) written on small pieces of paper folded to hide the number and mixed in the box. The number drawn will be found in the pre‐established group (see allocation sequence above) in order to define the type of primary dressing that will be administered. The number drawn will be excluded from the bo Xand will not participate in future draws. The induction of anesthesia will be preceded by antibiotic prophylaxis with ampicillin 2 g in adults and 100 mg/kg in children by slow direct intravenous injection (single dose) and the operating checklist. Disinfection of the donor site will pr CONDITION: Split‐thickness skin graft donor site wound ; Skin and Connective Tissue Diseases PRIMARY OUTCOME: Time to complete wound epithelialization assessed using a sterile transparent plastic measuring guide from the Medline brand and the Bates‐Jensen Wound Assessment Tool (BWAT) on Days 7, 10, 13, 16, 20, 24 and 28 SECONDARY OUTCOME: 1. Wound‐related background pain measured using visual analogue scale (VAS) and the Wong‐Baker Scale on days 7, 10, 13, 16, 20, 24 and 28; 2. Rate of wound infection measured using culture and sensitivity of wound swab whenever clinical sign of infection is suspected; 3. Quality of scar measured using the Patient and Observer Scar Assessment Scale (POSAS) at day 28; 4. The economic value of the dressing material measured using the Incremental Cost‐Effectiveness Ratio (ICER) at complete wound epithelialization INCLUSION CRITERIA: 1. Aged 5 to 45 years old 2. Requiring split‐thickness skin graft 3. Clinically stable 4. Consented to the study 5. Extent of the donor site wound is less than 10% of the body surface area
Epistemonikos ID: b9ac5c29fef8e69af56471b7e181e870ba687402
First added on: Aug 28, 2024