Neck Abscess Clinical Trial
Official title:
Vacuum Assisted Closure in Deep Neck Abscess
The presence of deep abscess in the neck is potentially severe, it can also lead to death in short term. The surgical treatment is indicated when there is commitment of the airway, critical condition, septicemia, complications, descendent infections, diabetes mellitus with no improving during the first 48 hours of parenteral antibiotic treatment and subsequent healing of the wounds until it heals by second intention. In this study investigators propose the use of vacuum Assisted Closure (VAC) that has been used satisfactorily to reduce edema, promote granulation, and ameliorate the tissue to afterwards reconstruct the defect, increase vascularity and diminish the bacterial load.
Objective: To evaluate the therapeutic efficacy of the combination of vacuum-assisted in
comparison with traditional therapy in wound healing in deep neck abscess.
Material and Methods Type of Study: Clinical Trial (Randomized) controlled This project was
performed in patients from the Service of Otolaryngology, IMSS, diagnosed with deep neck
abscess.
Procedure There were two groups: Group A, 14 patients treated with VAC therapy, group B,
patients treated with conventional therapy Group A: within the first three days the VAC
therapy will be placed , proceeding as follows : organize the material , bandage removal ,
cleaning of the wound with irrigation solution , cut the sponge and placement on the wound ,
use of polyvinyl alcohol and / or silver foam, insertion of the tube seal and connection to
the containing recipient. Wound cleaning will performed with irrigating solution and
replacement of the sponges every 72 hours according to evolution, photographs will be taken
to assess the percentage of viable tissue and granulation. A Sample to culture will be taken
prior to placement of VAC therapy , during the use of it and at the time of removal of the
system. When the wound presents clinical signs of improvement (elimination of purulent
discharge and granulation tissue ) VAC therapy will be withdrawn , and follow by delayed
primary closure.
Patients will be assign to group B: 14 patients on admission, after surgical drainage, a
culture will be taken, photographs every three days (during hospital stay ) and secretion
culture; daily cleaning stipulated by the service will be perform. The control of the
patients will be made until wound closure (presence of epithelialization tissue) .
Statistical Analysis Nominal variables will be analyzed using percentage frequencies, X2
test or Fisher exact test. Numeric variables using Student's t test for independent samples
and ANOVA with post hoc Scheffe test. U Mann Whitney and Kruskal Wallis tests will be used
as long as data do not conform to normal distribution. All values of p <0.05 will be
considered statistically significant. The analysis will be perform with statistical program
SPSS v. 18 for Windows program.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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