Phase III clinical trial. Use of the adhesive Tisuacryl tissue in wound closure of the oral-facial complex
Abstract
Effectiveness and safety of tissue adhesive Tisuacryl as alternative
method for wound management in oral and facial tissues were evaluated. A phase
III clinical trial was conducted in 26 hospitals and odontological clinical institutions
all around the country. Four hundred thirty nine patients, males and females,
from 0 to 80 years old who consented, were enrolled during a 16 month period.
Treated wounds included non deep facial
and mucogingival incisions and
traumatic lacerations. Exclusion criteria
included pregnancy, mental illness, animal
or human bite wounds, heavily contaminated
wounds needing debridement,
scratch or puncture wounds and
wounds in cutaneous or mucosal areas
under tension or that have been irradiated.
Facial wounds up to 3 cm length
and mucosal wounds up to 5 cm length,
both having up to 0.5 cm width, were included
in the clinical trial. All enrolled
patients received one topical application
of Tisuacryl over the manually opposed
wound edges. The wounds were held for
60 s until polymerization takes place.
The principal variable for effectiveness
assessment (dehiscence) was evaluated
at two follow-up periods: 5 to 15 min and
7 to 9 d . Quality of healing for skin wounds,
conformity of patients and physicians
were also evaluated as secondary outcome
measures. Physician skill and
wound length were measured as control
variables. Tissue adhesive Tisuacryl effectively
closes selected wounds in oral
mucose (97.1 %) and facial skin (95.2 %),
with an average score of 3.4 % of wound
dehiscence. In any patients secondary
dehiscence (after 7 to 9 d follow-up visit),
were found. No infected wounds or other
adverse effect related to the adhesive
were reported. Physician skills and
wound length were the variables that
most influenced the dehiscence score
rate. Quality of healing measured as adequate
scar appearance of skin wounds
at one month follow-up, was good in
85 % of patients. Patients and physicians
reported a high level of satisfaction with
the wound adhesion.
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