Clinical Trial to determine efficacy and safety of healing with platelet-rich

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2016
INTERVENTION: Trade Name: FURACIN POMADA Product Name: NITROFURAZONE OINTMENT Product Code: POMADA Pharmaceutical Form: Ointment INN or Proposed INN: NITROFURAL CAS Number: 59‐87‐0 Current Sponsor code: POMADA Other descriptive name: FURACIN POMADA Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 2‐ Product Name: LEUCOCYTES, FIBRINE AND PLATELET RICH PLASMA CLOT Product Code: COAGULO DE PLASMA Pharmaceutical Form: Gel INN or Proposed INN: L‐PRF Current Sponsor code: L‐PRF Other descriptive name: PLASMA Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 4‐ CONDITION: THE POST‐OPERATIVE OF NAIL SURGERY WITH PHENOL 88% TECHNIQUE IN SUBJECTS WITH ONYCOCRYPTOSIS IN BOTH FIRST TOES HEALINGS WITH NITROFURAZONE OINTMENT OR LEUCOYTES, FIBRINE AND PLATELETS PLASMA CLOT. Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Therapeutic techniques [E02] PRIMARY OUTCOME: Main Objective: DETERMINING THE IMPROVEMENT OF POSTOPERATIVE PROCESS WITH HEALING WITH LEUCOCYTES, FIBRINE AND PLATELETS RICH PLASMA CLOT IN COMPARISON WITH THE STANDARD HEALING WITH NITROFURAZONE OINTMENT. Primary end point(s): DECREASE THE DAYS OF TOTAL HEALING OF THE SURGERY NAIL THROUGHT PHENOL 88% TECHNIQUE AROUND 30%. Secondary Objective: DETERMINING:; ; ‐ POSTOPERATIVE HEALING'S DAYS.; ‐ POSTOPERATIVE HEMORRHAGE.; ‐ POSTOPERATIVE PAIN.; ‐ POSTOPERATIVE INFLAMMATION.; ‐ PRESENCE OF POSTOPERATIVE INFECTION. Timepoint(s) of evaluation of this end point: THE EVALUATION OF THIS POINTS WILL BE 48H POSTOPERATIVE, LATER THE CURES DURING FIVE DAYS CONSECUTIVES, AND LATER EVERY 48H SINCE THE WOUND WILL BE TOTALLY CURED. SECONDARY OUTCOME: Secondary end point(s): 1. DECREASE PRESENCE OF HEMORRHAGE POSTOPERAITVE IN 70%.; 2. DECREASE POSTOPERATIVE PAIN IN 70%.; 3. DECREASE POSTOPERATIVE INFLAMATION IN 50%.; 4. DECREASE PRESENCE OF POSTOPERATIVE INFECTIONS IN 80%. Timepoint(s) of evaluation of this end point: 1. OBSERVED IN FIRST CURE ONLY AT 48H LATER TO SURGERY. DOUBLE BLIND.; 2. EVALUATED WITH A VISUAL ANALOGICAL SCALE PUNTUATION IN THREE FIRST DAYS POST‐OPERATIVE.; 3. ONE MEASUREMENT WILL BE TAKE BEFORE SURGERY AND OTHER MEASUREMENT AT 48H POST‐OPERATIVE FOR THE SAME INVESTIGATOR.; 4. WILL BE OBSERVED AROUND ALL THE PROCESS OF HEALING. INCLUSION CRITERIA: ‐ PEOPLE OVER 18 YEAR. ‐ DIAGNOSED OF ONYCOCRYPTOSIS. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 70c9484cd4ca0db73f7d7b1b427d06059d74eb9c
First added on: Aug 24, 2024