Chitosan Unguent in burned patients

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Evaluation of the effect of Chitosan Unguent at 1% in the treatment of patients with first and second degree superficial burns

Secondary indentifying numbers:

EC00117

Issuing authority of the secondary identifying numbers:

Center for Pharmaceutical Research and Development, Havana, Cuba.

Source(s) of monetary or material support:

Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Rilder

Last name:

Acosta Vaillant

Medical Specialty :

Doctor in Medicine, First Degree Specialist in Plastic Surgery and Caumatology.

Affiliation:

Central Military Hospital "Dr. Luis Diaz Soto ", Havana, Cuba.

Postal address:

Avenida Monumental and Carretera del Asilo, Habana del Este.

City:

Havana

Country:

Cuba

Zip Code:

19130

Telephone:

+53-77680466

+53-77680467

Email address:

rilderacosta@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Central Military Hospital "Dr. Luis Diaz Soto ", in evaluation

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

02/04/2018

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Superficial first and second degree burns

Health condition(s) code:

Burns

Wounds and Injuries

Intervention(s):

Chitosan group (Experimental): Daily application of 1% chitosan unguent on the lesions after wound cleaning. Depending on the clinical course, the daily application will be continued until 14 days or before if the lesions are healed. Placebo group (Control): Daily placebo application on the lesions after wound cleaning. Depending on the clinical course, the daily application will be continued until 14 days or before if the lesions are healed.

Intervention code:

Chitosan

Ointments

Placebos

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Time of lesions healing (Time from baseline assessment until the moment of total healing of the lesions or the moment of formation of useful granulation tissue in the affected area). Measurement time: daily during the duration of the treatment.

Key secondary outcomes:

1. Extension of lesions (It will calculate using a simple method named Kirschbaum Rule or rule of 3, which constitutes a modification of the Wallace Rule (or rule of 9), by which it is considered that Different bodily anatomical regions represent 9% each or a multiple of 9% of total body surface area). Measurement time: at baseline and, then at days 7 and 14 of treatment or until the time of healing of the lesions. 2. Presence of local adverse events-AE (distribution frequency for the appearance of AE (Yes, No), type of event (name of the AE), duration (time from appearance until stop the event), severity (severe, non-severe), intensity of AE (grades 1-5), relation of causality (remote, possible, probable, very probable), result of AE (recuperate, improvement, persist or sequels), attitude concerning the studied treatment (without changes, dose modification, temporal or definitive treatment discontinuation)). Measuring time: At each administration until the end of treatment.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

70 years

Inclusion criteria:

1- Cuban patients, of any sex, any skin color, with superficial burns, grades I and II. 2- Ages between 18 and 70 years, both inclusive. 3 - Burns by physical agents. 4- Written informed consent of the patient to participate in the investigation and to complete the established examinations.

Exclusion criteria:

1- Burns from electrical or chemical origin, by inhalation or combined. 2 - Presence of microbiologically confirmed sepsis in the lesions, caused by Pseudomonas aeruginosa or other bacterial agents. 3- History of allergy or hypersensitivity to any component of the formulation. 4- Diabetes mellitus. 5- Referred immunological disease. 6- Malignant disease. 7- Collagen disease. 8- Pregnancy, breastfeeding or puerperium. 9- Severe psychiatric disorder or mental incapacity.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2

Target sample size:

40

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Idrian

Last Name:

Garcia Garcia

Specialty:

PhD in Health Sciences. Bachelor in Pharmaceutical Sciences. Master in Experimental Pharmacology.

Affiliation:

Center for Pharmaceutical Research and Development

Postal Address:

Ave. 26 and Calzada de Grandes Puentes, # 1605, Plaza de la Revolucion.

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

+53-78811844 ext. 144.

Email :

idrian.garcia@cidem.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Idrian

Last Name:

Garcia Garcia

Specialty:

PhD in Health Sciences. Bachelor in Pharmaceutical Sciences. Master in Experimental Pharmacology.

Affiliation:

Center for Pharmaceutical Research and Development

Postal Address:

Ave. 26 and Calzada de Grandes Puentes, #1605, Plaza de la Revolucion.

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

+53-78811844 ext. 144.

Email :

idrian.garcia@cidem.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000256

Date of Registration in Primary Registry:

16/10/2017

Record Verification Date:

2017/10/16

Next update date:

2018/10/16

Link to the spanish version:

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Chitosan Unguent in burned patients

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