Comparison of the effectiveness of the surgery healing the nail between an extracted blood product which is rich in platelets , fibrin and leukocytes and traditional healing with an antibiotic ointment .
Phase 1
- Conditions
- 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]
- Registration Number
- EUCTR2016-002048-18-ES
- Lead Sponsor
- IVERSIDAD REY JUAN CARLOS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
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
Exclusion Criteria
PEOPLE:
-OVER 65 YEARS.
-WITH DIABETES MELLITUS.
-WITH OPEN WOUNDS ON THE TOES.
-WITH ALLERGICS BACKGROUND TO COMPONENTS USED.
-WITH ATOPIC DERMATITIS OR OTHERS PROBLEMS IN THE SKIN OF TOES.
-WITHOUT CONTROL OF SYSTEMIC DISEASES.
-WITH PERIPHERAL VASCULAR DISEASE.
-WITHOUT MOTOR OR COGNITIVE CAPACITY.
-WITH ANTICOAGULANT TREATMENT.
-DISCONFORM WITH INFORMED CONSENTIMENT.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;<br> Secondary Objective: DETERMINING:<br><br> - POSTOPERATIVE HEALING'S DAYS.<br> - POSTOPERATIVE HEMORRHAGE.<br> - POSTOPERATIVE PAIN.<br> - POSTOPERATIVE INFLAMMATION.<br> - PRESENCE OF POSTOPERATIVE INFECTION.<br> ;Primary end point(s): DECREASE THE DAYS OF TOTAL HEALING OF THE SURGERY NAIL THROUGHT PHENOL 88% TECHNIQUE AROUND 30%.;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 Measures
Name Time Method <br> Secondary end point(s): 1. DECREASE PRESENCE OF HEMORRHAGE POSTOPERAITVE IN 70%.<br> 2. DECREASE POSTOPERATIVE PAIN IN 70%.<br> 3. DECREASE POSTOPERATIVE INFLAMATION IN 50%.<br> 4. DECREASE PRESENCE OF POSTOPERATIVE INFECTIONS IN 80%.<br> ;<br> Timepoint(s) of evaluation of this end point: 1. OBSERVED IN FIRST CURE ONLY AT 48H LATER TO SURGERY. DOUBLE BLIND.<br> 2. EVALUATED WITH A VISUAL ANALOGICAL SCALE PUNTUATION IN THREE FIRST DAYS POST-OPERATIVE.<br> 3. ONE MEASUREMENT WILL BE TAKE BEFORE SURGERY AND OTHER MEASUREMENT AT 48H POST-OPERATIVE FOR THE SAME INVESTIGATOR.<br> 4. WILL BE OBSERVED AROUND ALL THE PROCESS OF HEALING.<br>