Cutaneous Use of Tisuacryl®

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000046
• Date of registration: 30/09/2008
• Primary sponsor: Center of Biomaterials of Havana University
• Public title: Cutaneous Use of Tisuacryl®
• Scientific title: Use of tissue adhesive Tisuacryl® in the closure of skin wounds
• Date of first enrolment: 06/01/2003
• Target sample size: 674
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000046-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Dr. Mayra Perez Alvarez
• Affiliation: Clínica Docente Estomatológica of Bauta

• Name: Dr. Rosa Guerra Bretaña
• Affiliation: Center of Biomaterials, University of Havana

Key inclusion & exclusion criteria

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

Age minimum: 1 years
Age maximum: 80 years
Gender: Both

Health Condition(s) or Problem(s) studied

Surgical and traumatic wonds

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

Primary Outcome(s)

Dehiscence, immediately and 7-11 days

Secondary Outcome(s)

Infection, 7-11 days Patient Satisfaction, 7-11 days Physician Satisfaction, 7-11 days Cosmetic appearance of the scar, 30 days

Secondary ID(s)

EC2

Source(s) of Monetary Support

Center of Biomaterials of Havana University