Clinical Trial Results:
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.
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Summary
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EudraCT number |
2016-002048-18 |
Trial protocol |
ES |
Global end of trial date |
30 May 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Nov 2021
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First version publication date |
18 Nov 2021
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Other versions |
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Summary report(s) |
RESULTADOS |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
16/195
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
XAVIER GARRIDO CASTELLS
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Sponsor organisation address |
Plaza España, 14-1, Canals, Spain, 46650
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Public contact |
XAVIER GARRIDO CASTELLS, XAVIER GARRIDO CASTELLS, 34 661451622, xavi3garrido@hotmail.com
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Scientific contact |
XAVIER GARRIDO CASTELLS, XAVIER GARRIDO CASTELLS, 34 661451622, xavi3garrido@hotmail.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
15 May 2019
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 May 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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Protection of trial subjects |
All subjects was free of diseases and all signed a informated consentiment.
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Background therapy |
All patients results with a satisfactory ended for the resolutions of their problem. | ||
Evidence for comparator |
The LPRF obtaining in general conclusion, a improvement in the days of healing respect the standrad healing. This days was around 7 days less with aplications of LPRF. | ||
Actual start date of recruitment |
16 May 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 40
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Worldwide total number of subjects |
40
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EEA total number of subjects |
40
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
40
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The recruitment of patients was carried out as cases were presented in the clinic, taking into account all the elements determined for the selection. | |||||||||
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Pre-assignment
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Screening details |
Onichocryptosis stage I and IIa. | |||||||||
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Period 1
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Period 1 title |
All study (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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LPRF Patiens | |||||||||
Arm description |
Patients withs aplications postsurgical of LPRF | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Leucocyte and Platelet rich firbin
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Investigational medicinal product code |
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Other name |
Leucocyte and Platelet rich firbin
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Pharmaceutical forms |
Blood fraction modifier
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Routes of administration |
Epicutaneous use , External use
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Dosage and administration details |
5 ml of blood are necesary to building ths clot of LPRF
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Arm title
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Patients with standard healing | |||||||||
Arm description |
Patients with the aplication of nitrofurazone cream to healing the surgical wound | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Nitrofurazone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Epicutaneous use , External use
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Dosage and administration details |
A gauze with 2 ml approximately were applied
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Baseline characteristics reporting groups
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Reporting group title |
All study
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Reporting group description |
The socio-demographic baseline characteristics (sex, age, weight, height, and body mass index (BMI)) of patients were collected by the same physician who performed the chemical matrixectomy surgery with 88% phenol in a sterile manner according to the protocol of Becerro-de-Bengoa-Vallejo et al. [9]. After the surgery, the hallux was washed with a bristled sterile brush and dual-sided foam saturated with povidone iodine for approximately 5 min. Next, the toenail was wiped clean with sterile gauze and disinfected with 10% povidone-iodine. Subsequently, 2 mL of 2% mepivacaine (without vasoconstrictor) as a local anesthetic was injected. Next, a digital tourniquet was laid at the base of the hallux of the foot. In addition, the nail plate spicule was retrieved at each border (medial and lateral) with a Kelly hemostat. Residual blood in the zone was cleaned with a sterile gauze and then three rounds were applied with a phenol solution for 1 min at each border of the toenail with the termi | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
All Analysis
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The primary outcome measurement was post-surgical bleeding, which was categorized as mild (the dressing did not show external spots; only the polypropylene of the dressing was in contact with the wound, and the gauze was in contact with the dressing), moderate (the dressing might have shown slight spots on the back or sides; the non-adherent dressing might have been completely stained and the gauze in contact with it may have been partially stained), or heavy bleeding (the external bandage could be completely or almost completely colored) [17]. The secondary outcome measurements were post-surgical pain intensity as assessed by the visual analogue scale (VAS, showing an intraclass correlation coefficient of 0.97) on the first, second, and third days after surgery [18], post-surgical inflammation as measured by the digital circumference in mm using a flexible ruler (Devon Industries 1-800, Inc., Devon, PA, USA) at the level of the proximal nail fold before and 48 h after surgery during
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End points reporting groups
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Reporting group title |
LPRF Patiens
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Reporting group description |
Patients withs aplications postsurgical of LPRF | ||
Reporting group title |
Patients with standard healing
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Reporting group description |
Patients with the aplication of nitrofurazone cream to healing the surgical wound | ||
Subject analysis set title |
All Analysis
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The primary outcome measurement was post-surgical bleeding, which was categorized as mild (the dressing did not show external spots; only the polypropylene of the dressing was in contact with the wound, and the gauze was in contact with the dressing), moderate (the dressing might have shown slight spots on the back or sides; the non-adherent dressing might have been completely stained and the gauze in contact with it may have been partially stained), or heavy bleeding (the external bandage could be completely or almost completely colored) [17]. The secondary outcome measurements were post-surgical pain intensity as assessed by the visual analogue scale (VAS, showing an intraclass correlation coefficient of 0.97) on the first, second, and third days after surgery [18], post-surgical inflammation as measured by the digital circumference in mm using a flexible ruler (Devon Industries 1-800, Inc., Devon, PA, USA) at the level of the proximal nail fold before and 48 h after surgery during
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End point title |
Days of healing | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
The days of healing were from the day of the intervention until the healing criteria were met.
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| Notes [1] - ONE OF THE HALLUCIS OF OURS PATIENTS [2] - ONE OF THE HALLUX OF OUR PATIENTS |
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Statistical analysis title |
FINAL ANALYSIS | ||||||||||||
Statistical analysis description |
WAS THE ANALYSIS OF THE DAYS FOR COMPLET THE HEALING IN BOTH GRUPS
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Comparison groups |
LPRF Patiens v Patients with standard healing
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
5 | ||||||||||||
upper limit |
95 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
5
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Statistical analysis title |
FINAL ANALYSIS | ||||||||||||
Statistical analysis description |
WAS THE ANALYSIS OF THE DAYS FOR COMPLET THE HEALING IN BOTH GRUPS
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Comparison groups |
LPRF Patiens v Patients with standard healing
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
5 | ||||||||||||
upper limit |
95 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
5
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Adverse events information [1]
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Timeframe for reporting adverse events |
No report any case of adverse events
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
10.0
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: THE INFLAMMATION HAPPEN IN SOME PATIENT FOR THE APPLICATION OF PHENOL, BUT IT IS A NORMAL REACCTION IN THIS TECHNIQUE. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| the limitations of our study were in the only one location to select our subjects to study, nothing more limitations. | |||
