Western Medical Center, Mexican Institute of Social Security
Guadalajara, Jalisco, 44340, Mexico
NCT Number: NCT02102685
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Guadalajara, Jalisco, 44340, Mexico
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presents clinical signs of improvement (elimination of purulent discharge and granulation tissue ) VAC therapy will be withdrawn , and follow by delayed primary closure.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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
within the first three days the VAC therapy was placed , proceeding as follows : Wound cleaning was performed with irrigating solution and replacement of the sponges every 72 hours according to evolution, photographs were taken to assess the percentage of viable tissue and granulation. A Sample to culture was 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 was withdrawn , and follow by delayed primary closure.
after surgical drainage, a culture was taken, photographs every three days (during hospital stay ) and secretion culture; daily cleaning stipulated by the service was perform. The control of the patients were made until wound closure (presence of epithelialization tissue) .
Time frame: every 3 days up to 3 months
the percentage of granulation tissue will be evaluated by a software called image Image J
Time frame: every 3 days up to 3 months
haematoma, and wound dehiscence
Time frame: every 7 days up to 3 months
culture of the wound secretion
Time frame: Up to 6 months
deaths registered during the study
Instituto Mexicano del Seguro Social
Other Gov
Vacuum Assisted Closure in Deep Neck Abscess
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