Clinical Trials Register

Summary
EudraCT Number:	2015-000232-15
Sponsor's Protocol Code Number:	HIDROGEL-014
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2016-07-15
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2015-000232-15

A.3

Full title of the trial

Analgesic efficacy of levobupivacaine administered by wet wound dressing for the management split-thickness skin graft donor sites

Eficacia analgésica de la levobupivacaína administrada mediante apósitos de cura en ambiente húmedo sobre zonas donantes de injertos de piel parcial

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Analgesic efficacy of levobupivacaine administered by wet wound dressing on skin graft donor site

Eficacia analgésica de la levobupivacaína administrada mediante apósitos en lan
zonas donantes del injerto de piel.

A.3.2

Name or abbreviated title of the trial where available

HIDROGEL-014

A.4.1

Sponsor's protocol code number

HIDROGEL-014

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Consorcio Hospital General Universitario de Valencia . Servicio de Anestesia , Reanimacion y tto del Dolor
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Consorcio Hospital General Universitario de Valencia . Servicio de Anestesia , Reanimacion y tto del Dolor
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Consorcio Hospital General Universitario de Valencia .
B.5.2	Functional name of contact point	Serv de Anestesia, Reanimacion
B.5.3	Address:
B.5.3.1	Street Address	Avda Tres Cruces, 2
B.5.3.2	Town/ city	Valencia
B.5.3.3	Post code	46014
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34617322858
B.5.5	Fax number	+34961972303
B.5.6	E-mail	molinervelazquez@gmail.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	CHIROCANE 7,5 mg/ml SOLUCION INYECTABLE
D.2.1.1.2	Name of the Marketing Authorisation holder	ABBVIE FARMACEUTICA, S.L.U.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEVOBUPIVACAINE
D.3.9.1	CAS number	27262-47-1
D.3.9.2	Current sponsor code	chirocane
D.3.9.3	Other descriptive name	levobupivacaine
D.3.9.4	EV Substance Code	SUB08464MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	7.5 to 150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection in pre-filled syringe
D.8.4	Route of administration of the placebo	Topical use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

acute postoperative pain

Dolor agudo postoperatorio

E.1.1.1

Medical condition in easily understood language

postoperative pain

dolor tras intervencion quirurgica

E.1.1.2

Therapeutic area

Diseases [C] - Symptoms and general pathology [C23]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

evaluate the analgesic efficacy of L-Bupivacaine 0.75% (max 20 ml) vs.placebo (saline) administered by wet wound dressing for the management split-thickness skin graft donor sites

Probar la eficacia analgésica de hasta 20 ml de volumen de L-Bupivacaina 0,75% vs placebo (suero fisiológico), administrados topicamente con el
apósito de cura en ambiente húmedo en la zona donante del injerto.

E.2.2

Secondary objectives of the trial

1 . Assess pain intensity at 24h by VAS. 2. Set the difference in analgesic requirements of intravenous tramadol consumption, as rescue medication, in each of the groups at 24 hours after the end of anesthesia. 3. Assess pain intensity at 72h by VAS. 4. the time until reepithelialization (up to 15 days).

1. Intensidad del dolor en la zona donante, medida con la escala de valoración del dolor EVA a las 24 horas en el postoperatorio inmediato. 2. Establecer la diferencia entre grupos en la necesidad de analgésicos utilizando para su valoración: el consumo de tramadol intravenoso en mg administrada en forma de rescate a todos los pacientes. Se evaluará a las 24 horas en el postoperatorio inmediato. 3. Intensidad del dolor en la zona donante, medida con la escala de valoración del dolor EVA a las 72 horas en el postoperatorio inmediato. 4. Tiempo transcurrido hasta la reepitelización completa de la herida quirúrgica de la zona donante (hasta 15 dias tras la intervención)

E.2.3

Trial contains a sub-study

E.2.3.1

Full title, date and version of each sub-study and their related objectives

1. Intensidad del dolor en la zona donante, medida con la escala de valoración del dolor EVA a las 24 horas en el postoperatorio inmediato.
2. Establecer la diferencia entre grupos en la necesidad de analgésicos utilizando para su valoración: el consumo de tramadol intravenoso en
mg administrada en forma de rescate a todos los pacientes. Se evaluará a las 24 horas en el postoperatorio inmediato.
3. Intensidad del dolor en la zona donante, medida con la escala de valoración del dolor EVA a las 72 horas en el postoperatorio inmediato.
4. Tiempo transcurrido hasta la reepitelización completa de la herida quirúrgica de la zona donante (hasta 15 dias tras la intervención)

E.3

Principal inclusion criteria

1. Patients> 18 and <= 75 years. 2. Patients had an split-thickness skin graft donor site area of 50?150 cm2. 3. Skin graft donor site anterior or
posterior thigh. 4. Hospitalization of at least 72 hours. 5. Informed consent signed

1. Pacientes mayores de 18 años y menores o igual a 75 años.2.Pacientes con defectos cutáneos susceptibles de ser cubiertos por injerto de piel parcial de superficie entre 50 y 150 cm2. 3.Zona donante en la cara anterior o posterior del muslo. 4. Ingreso hospitalario previsto de al menos 72 horas tras la cirugía. 5. Firma del consentimiento informado.

E.4

Principal exclusion criteria

1. Rejection of the patient 2. Surgical procedure superior than 6hrs.3.Other conditions that warrant their inclusion as medically indicated: severe kidney illness (grade 3-4). severe hepatic illness (ChildPugh B and C grades), psychiatric illness), arrythmias, coagulation disorders, preganacy o lactation.
4. Allergy to NSAIDs, local anesthetics and / or opioids. 5. Alcoholism. 6. Abuse drugs. 7. ASA III or higher 8. When the surgery procedure time is 1 hour
more from the moment of obtention of the graft

1. Rechazo de la paciente. 2 Tiempo quirúrgico mayor de 6h de duración 3 Otras enfermedades que aconsejen su no inclusión según criterio médico: patología severa renal (estadio 3 y 4), patología hepática (ChildPugh estadios B y C) o psiquiatrica, trastornos del ritmo cardiaco, trastornos de la coagulación, el embarazo y la lactancia.4. Alergia a AINES, anestésicos locales y/o a mórficos. 5 Alcoholismo. 6. Adicción a drogas. 7. Estado funcional ASA>3 8. Intervención quirúrgica que se prolongue mas de 1 hora tras obtener la pieza del injerto.

E.5 End points

E.5.1

Primary end point(s)

Patient-reported postoperative pain, evaluated by a Visual Analog Scale (VAS)

La intensidad del dolor medido con la escala de valoración del dolor EVA

E.5.1.1

Timepoint(s) of evaluation of this end point

At 6 hours from wet wound dressing is placed over donor site.

A las 6 horas de la colocación del apósito de cura.

E.5.2

Secondary end point(s)

Efficacy: 1.Patient-reported postoperative pain. evaluated by a Visual Analog Scale (VAS). 2. Intravenous Tramadol used (mg).
3. the time until reepithelialization of donor site.
Safety: 1. Adverse events and unwanted systemic and locally side effects that the patient relate and observed by investigators. 2. Other explorations carried out occasionally or symptoms that the patient relate.

Eficacia: 1.La intensidad del dolor medido con la escala de valoración del dolor EVA . 2. Consumo de tramadol intravenoso en mg . 3. Tiempo hasta la reepitelización de la zona donante. Seguridad: 1. Acontecimientos adversos, reacciones adversas locales y generales, comunicadas por el paciente y observadas por el personal sanitario. 2. Otras exploraciones que ocasionalmente se realicen o síntomas que el paciente relate.

E.5.2.1

Timepoint(s) of evaluation of this end point

Efficacy: 1. At 24 and 72 hours from wet wound dressing is placed over donor site, in point number 1. 2. At 24 hours, in point number 2. 3. From 7th to 15th days (every 72 hours), after surgery, in point number 3.
Safety: Every study visits.

Eficacia: 1. A 24 y 72 horas de la colocación del apósito húmedo en la zona donante, en el punto nº1. 2. A las 24 horas, en el punto nº2. 3. Desde el día 7 hasta como máximo 15 días tras la cirugía (cada 72 horas) , en el punto nº3. Seguridad: En todas las visitas del estudio.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

LVLS iis the last visit of the last subject enter.

El Final del Estudio es la última visita del último paciente incluido.

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

NONE

ninguno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-07-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-03-26

P. End of Trial
P.	End of Trial Status	Ongoing

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