E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
EL POST-OPERATORIO DE LA CIRUGIA UNGUEAL CON TÉCNICA DE FENOL AL 88% EN SUJETOS CON ONICOCRIPTOSIS EN AMBOS PRIMEROS DEDOS DEL PIE CURADOS CON POMADA DE NITROFURAZONA O CON COAGULO DE PLASMA RICO EN PLAQUETAS, LEUCOCITOS Y FIBRINA. |
|
E.1.1.1 | Medical condition in easily understood language |
THE PROCES POSTOPERATIVE OF NAIL SURGERY IN PEOPLE WITH INGROWN TOENAILS IN BOTH BIG TOES CURED WITH A ANTIBIOTIC OINMENT OR A PRODUCT OF BLOOD IN FORM OF CLOT. |
EL PROCESO POST-OPERATORIO DE LA CIRUGIA DE LA UÑA ENCARNADA DE LOS DOS DEDOS GORDOS DEL PIE CURADOS CON UNA POMADA ANTIBIÓTICA Y UN PRODUCTO DE LA SANGRE EN FORMA DE COAGULO. |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
DETERMINAR LA MEJORA DEL PROCESO POST-OPERATORIO CON LAS CURAS CON COAGULO DE PLASMA RICO EN PLAQUETAS, FIBRINA Y LEUCOCITOS EN COMPARACIÓN CON LA CURA ESTANDAR CON POMADA DE NITROFURAZONA. |
|
E.2.2 | Secondary objectives of the trial |
DETERMINING:
- POSTOPERATIVE HEALING'S DAYS. - POSTOPERATIVE HEMORRHAGE. - POSTOPERATIVE PAIN. - POSTOPERATIVE INFLAMMATION. - PRESENCE OF POSTOPERATIVE INFECTION. |
DETERMINAR:
- Los días de cicatrización de la herida post-quirúrgica. - La hemorragia post-operatoria. - El dolor post-operatorio. - Inflamación post-operatoria. - Presencia de infección. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- PEOPLE OVER 18 YEAR. - DIAGNOSED OF ONYCOCRYPTOSIS. |
- PERSONAS MAYORES DE 18 AÑOS.
- DIAGNOSTICADAS DE ONICOCRIPTOSIS. |
|
E.4 | Principal 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. |
- Personas mayores de 65 años. - Personas con Diabetes Mellitus. - Personas con heridas abiertas en los dedos del pie. - Personas con antecedentes personales de alergias a cualquiera de los ingredientes de las soluciones empleadas o contraindicación para su uso. - Personas con dermatitis atópica o cualquier otra alteración de la piel de los dedos del pie que no garantice su continuidad. - Personas con enfermedad sistémica mal controlada o que contraindique la intervención. - Personas con enfermedad periférica vascular. - Personas con incapacidad cognitiva y/o motora para poder seguir las instrucciones postquirúrgicas. - Personas en tratamiento con anticoagulantes. - Personas que no acepten ni firmen el consentimiento informado. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
DECREASE THE DAYS OF TOTAL HEALING OF THE SURGERY NAIL THROUGHT PHENOL 88% TECHNIQUE AROUND 30%. |
DISMINUIR LOS DIAS DE CURACIÓN TOTAL DE LA CIRUGIA UNGUEAL POR LA TÉCNICA DE FENOL AL 88% EN UN 30%. |
|
E.5.1.1 | 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. |
LA EVALUACION DE ESTE PUNTO SERÁ A LAS 48 HORAS POST-OPERATORIAS, DESPUÉS DURANTE 5 DIAS CONSECUTIVOS, Y DESPUES CADA 48 HORAS HASTA LA CURACIÓN TOTAL DE LA HERIDA. |
|
E.5.2 | 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%. |
1. DISMINUIR LA PRESENCIA DE HEMORRAGIA POST-OPERATORIA EN UN 70%. 2. DISMINUIR EL DOLOR POST-OPERATORIO EN UN 70%. 3. DISMINUIR LA INFLAMACION POST-OPERATORIA EN UN 50%. 4. DISMINUIR LA PRESENCIA DE INFECCIÓN EN UN 80%. |
|
E.5.2.1 | 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. |
1. OBSERVADO EN LA PRIMERA CURA SOLAMENTE A LAS 48 HORAS DESPUES DE LA CIRUGIA. DOBLE CIEGO. 2. EVALUADO CON UNA PUNTUACIÓN EN UNA ESCALA ANALOGICA VISUAL DEL DOLOR DURANTE LOS TRES PRIMEROS DIAS POSTQUIRÚRGICOS. 3. UNA MEDIDA SE TOMARA ANTES DE LA CIRUGIA Y OTRA A LAS 48 HORAS DESPUES DE LA MISMA. 4. SERA OBSERVADO DURANTE TODO EL PROCESO DE CURACIÓN. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial is make a improvement in the post-operative process of nail surgery through phenol 88% technique. This technique of surgery have a hight points of effectiveness, but it exist a retardation healing process of surgery wound. With the use of leucocytes, fibrine and platelets rich plasma clot, we want take a solution a this problem and dcrease the number of complications like the infections rate and recurrences. |
El fin del estudio es mejorar el proceso post-operatorio de la cirugía ungueal mediante técnica de fenol al 88%. Dicha técnica tiene una alta efectividad pero existe una cicatrización retardada de la herida quirúrgica. Mediante la utilización del coagulo de plasma rico en plaquetas, leucocitos y fibrina, en las curas, pretendemos dar solución a esta problemática y reducir el número de complicaciones como la tasa de infecciones y recidivas. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |