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 .

Clinical Trial to determine efficacy and safety of healing with platelet-rich plasma, fibrin and leukocytes compared to standard healing with nitrofurazone ointment in subjects with onychocryptosis. - Clinical Trial to determine efficacy and safety of healing with L-PRF in Onychocryptosis Surgery.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002048-18-ES

Enrollment

Registered

2016-11-22

Start date

2016-11-21

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: FURACIN POMADA Product Name: NITROFURAZONE OINTMENT Product Code: POMADA Pharmaceutical Form: Ointment INN or Proposed INN:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.; Secondary Objective: DETERMINING: - POSTOPERATIVE HEALING'S DAYS. - POSTOPERATIVE HEMORRHAGE. - POSTOPERATIVE PAIN. - POSTOPERATIVE INFLAMMATION. - PRESENCE OF POSTOPERATIVE INFECTION. ;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.	—

Measure

Time frame

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.; Secondary Objective: DETERMINING: - POSTOPERATIVE HEALING'S DAYS. - POSTOPERATIVE HEMORRHAGE. - POSTOPERATIVE PAIN. - POSTOPERATIVE INFLAMMATION. - PRESENCE OF POSTOPERATIVE INFECTION. ;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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Spain

Contacts

Public ContactXAVIER GARRIDO CASTELLS

UNIVERSIDAD REY JUAN CARLOS

xavi3garrido@hotmail.com34661451622

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026