Tisuacryl® in Dentistry

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:

Use of tissue adhesive Tisuacryl® in the closure of oral and facial wounds

Secondary indentifying numbers:

EC1

Issuing authority of the secondary identifying numbers:

Center of Biomaterials of Havana University

Source(s) of monetary or material support:

Center of Biomaterials of Havana University

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:

Only approved by Ethics Committees

Principal investigator

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

First name:

Mayra

Midle name:

de la Caridad

Last name:

Perez Alvarez

Medical Specialty :

General Stomatologist

Affiliation:

Clinical Stomatology Educational of Bauta

Postal address:

Ave 251 No. 13201 e/ 132 y 134, Bauta

City:

Artemisa

Country:

Cuba

Zip Code:

32400

Telephone:

+53-047372623

Email address:

email@not.entered [1]

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:

Havana, Faculty of Dentistry Dr. Alexander Segui Ulloa

Havana, Clinic L y 23, Dra. Isabel Trutman Vinagera

Havana, Policlinic 5 de Septiembre, Dra. Maria Acelia Marrero Miragaya

Havana, Hospital General Docente Aleida Fernandez Chardiet, Dr. Orlando L. Rodriguez Calzadilla

Pinar del Rio, Hospital Abel Santamaría, Dr. Higinio Hernández González

Matanzas, Clinic Sede III Congreso del PCC, Dra. Olga Febles Lebrigios

Matanzas, Hospital Faustino Perez, Dr. Jorge Hernandez Gonzalez

Cienfuegos, Hospital Provincial Gustavo Aldereguia, Dr. Bienvenido J. Mesa Reinaldo,

Villa Clara, Hospital Arnaldo Milian Castro, Dra. Elia Merle Chinea Meneces

Villa Clara, Clinic of Specialties, Dra. Caridad Nasco Rios

Sancti Spiritus Hospital Provincial Camilo Cienfuegos, Dr. Juan Antonio Santisteban Rodriguez

Ciego de Avila, Clinic Centro, Dr. Manuel Barreras Tacher

Ciego de Avila ,Hospital General Antonio Luaces Iraola, Dr. Manuel de J. Diaz Hernandez

Camaguey, Hospital Provincial Manuel Ascunce, Dr. Miguel Arredondo Lopez,

Camagüey, Hospital Pediátrico Eduardo Agramonte Pinna Dr. Fernando Lancara Mola,

Las Tunas, Hospital Ernesto Guevara Dr. Rolando Velazquez Reyes

Holguín, Clinic Manuel Angulo, Dra. Doris Joseph Montero,

Holguín, Clinic Mario Pozo, Dra. Malvina Chapman Tompson,

Holguín, Clinic Pedro del Toro, Dra Daysi C. Michael Goden,

Holguín, Clinic Artemio Mastrapa, Dra. Amelia Torango Reyes,

Granma, Hospital Celia Sanchez Dra. Gloria Matos Santo-Domingo,

Granma, Clinic of Specialties Manuel de J. Cedenno Dr. Saul Osiris Gongora Aguilar,

Santiago de Cuba, Clinic Provincial, Dr. Alexis de la Tejera Chillon,

Guantanamo, Clinic Lidia Doce, Dra. Marcia Colas Costa

Guantanamo, Hospital General Agustino Neto, Dr. Rafael Velazquez Salazar.

Research ethics committees:

Approved by Ethics Committee especially organized for the study, Septiembre 2001

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

06/12/2001

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:

Oral and facial surgical incisions and traumatic lacerations

Health condition(s) code:

Facial Injuries

Wounds and Injuries

Mouth

Face

Intervention(s):

Closure of oral and facial surgical incisions and traumatic lacerations All investigators received standardized training in the use of Tisuacryl®. For patients with multiple eligible wounds, the trial was limited to the bigger wound. Tisuacryl® was applied using the following techniques: Skin wounds were thoroughly irrigated, cleansed and carefully dried with sterile gauze. Oral wounds were disinfected with aqueous clorhexidine (2%). Wound edges were approximated with gloved fingers and several drops of the tissue adhesive were applied along the surface of the wound, forming a thin film. If necessary, the excess of the adhesive was eliminate with a flat instrument. Manual pressure was held for approximately 60 seconds to obtain adequate adhesion. The product remaining in the ampoule was not used in any other patients.

Intervention code:

Tissue Adhesives

Wound Closure Techniques

Intervention keyword:

Tisuacryl

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):

Dehiscence, immediately and 7-9 days.

Key secondary outcomes:

Patient Satisfaction, 7-9 days Physician Satisfaction, 7-9 days. Cosmetic appearance of the scar, 30 days

Selection criterias

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

Gender:

Male/Female

Minimum age:

1 years

Maximum age:

80 years

Inclusion criteria:

Adult patients up to 80 years old who consent to participate in the clinical trial Children more than 1 year old whose parents or tutors consent to participate in the clinical trial Patients who fulfill the established diagnostic criteria: 1) Non deep facial skin wounds that do not required subcutaneous suture; less than 3 cm in length and 0,5 cm in width. 2) Non deep oral wounds that do not required subcutaneous sutures; less than 5 cm in length and 0,5 cm in width.

Exclusion criteria:

Patients with wounds contaminated by foreign body Patients with wounds that require debridement Patients with crushing and puncture wounds or those produced by bites or scratches of animals or humans Patients with wounds in an area of important skin tension Patients with radiation therapy. Patients with mental incapacity and/or severe psychological disorders Pregnant and breastfeeding women Patients that do not consent to participate in the study

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:

N/A: single arm study

Masking:

Open

Control group:

Placebo

Study design:

Single group

Phase:

Target sample size:

439

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:

Rosa

Middle Name:

Mayelin

Last Name:

Guerra Bretaña

Specialty:

Doctor of Chemical Sciences

Affiliation:

Center of Biomaterials of Havana University

Postal Address:

Ave. Universidad e/ Ronda y G, Vedado

City:

La Habana

Country:

Cuba

Zip Code:

10300

Telephone:

(537)8735477

Email :

mayelin@biomat.uh.cu [2]

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:

Mayra

Middle Name:

de la Caridad

Last Name:

Perez Alvarez

Specialty:

General Stomatologist

Affiliation:

Clinical Stomatology Educational of Bauta

Postal Address:

Ave 251 No. 13201 e/ 132 y 134, Bauta.

City:

Artemisa

Country:

Cuba

Zip Code:

32400

Telephone:

53-047-374197

Email :

dntimefa@infomed.sld.cu [3]

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:

RPCEC00000044

Date of Registration in Primary Registry:

2008-09-12

Record Verification Date:

2008-09-03 20:00

Link to the spanish version:

Click here [4]