Cutaneous Use of Tisuacryl®

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 skin wounds

Secondary indentifying numbers:

EC2

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:

Pérez Alvarez

Medical Specialty :

Estomatóloga General

Affiliation:

Clinica Estomatologica Docente de Bauta

Postal address:

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

City:

Artemisa

País:

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, Surgery Service, General Calixto García Hospital, Dra. Rosalba Roque

Havana, National Center for Minimal Access Surgery, Dr. Rafael Torres Penna

Havana, Policlinic Corintia, Dr. Melesio Perez

Havana, Policlinic Luis de la Puente Uceda, Dr. Leonardo Gonzalez

Havana, Policlinic Mario Escalona, Dr. Ernesto Lezcano

Havana, Policlinic Lawton, Dr. Felix Cairo

Havana, Policlinic Victoria Cuba-Angola, Dra. Tamara Paredes

Havana, Paediatric Hospital Leonor Perez, Dra. Daysi Cordobes

Havana, Policlinic Gregorio Valdes, Dr. M. Rodriguez Mateo

Havana, Policlinic Pablo Noriega, Dr. Jose Robert Escalona

Research ethics committees:

Approved by Ethics Committee especially designed for the study, November 19, 2002

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

06/01/2003

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:

Surgical and traumatic wonds

Health condition(s) code:

Wounds and Injuries

Intervention(s):

Closure of traumatic and surgical wounds. Treatment was done within standard medical practice. In cases of multiple eligible wounds, all were treated with the product. However, only the biggest one was considered for the study. In Endoscopic Surgery all wounds were taken into account. The following steps were taken with laceration wounds: 1.- Cleansing with soap and water. 2.- Wounds were dried with sterile gauze. Bleeding was stopped through compression when necessary. 3.- Wound edges were approximated with the fingers. Microdrops of the product were applied on the surface of the approximated wound edges forming a fine film. The application was begun over the firmer part of the wound. Any excess product was separated with a flat instrument. 4.- Manual pressure was maintained for 60 seconds. Tisuacryl was applied on surgical wounds in the same way except for the inclusion of step 1. All ampoules were previously disinfected with clorhexidine before their introduction into the operating room. After applying the product, any remaining was discarded and not used in other patients. The same ampoule was used in a given patient if he had more than one wound. The product does not permit ulterior corrections so a careful initial and definite approximation of the wound edges must be done. In case dressings were needed, the product should be completely dry to avoid adhesion to other materials. Patients were told to shower with the applied tissue adhesive on the wound. However they must avoid scratching or injuring the wound in order to preserve the sealing effect of the product and prevent possible dehiscence. No topical creams or disinfectant solutions were applied over the sealed wound. Precautions were taken so chronic asthma patients did not inhale the vapors of the product. Contact of the product with gloves, dressings, or other material adhered to the skin was avoided. In case the product was spilled, lots of warm water was applied and acetone was used to cleanse the non damaged areas of the skin. Patients were told to return after a week to assess the wound.

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 7-11 days

Key secondary outcomes:

Infection, 7-11 days Patient Satisfaction, 7-11 days Physician Satisfaction, 7-11 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:

Patients of both genders, between 1 and 80 years old. Adult patients who gave the informed consent. Children whose parents or tutors signed the informed consent. Patients who fulfill the established diagnostic criteria:: 1)Surgical incisions less than 6 cm long which had subcutaneous sutures. Longer incisions could be considered using anchor sutures every 3-4 cm. 2)Recent (under 6 hours) non deep cutaneous lacerations (that do not require internal suture) less than 4 cm long and 0.5 cm in width.

Exclusion criteria:

Patients with wounds contaminated by any foreign body Patients with wounds produced by bites or scratch of animals or humans, puncture or crushing Patients with wounds located in an area of high skin tension 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:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

674

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, University of Havana

Postal Address:

Ave.Universidad e/ Ronda y G, Vedado.

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

78735477

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

País:

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:

RPCEC00000046

Date of Registration in Primary Registry:

2008-09-30

Record Verification Date:

2008-09-17 20:00

Link to the spanish version:

Click here [4]