- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02102685
Vacuum Assisted Closure in Neck Abscess
Vacuum Assisted Closure in Deep Neck Abscess
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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presents clinical signs of improvement (elimination of purulent discharge and granulation tissue ) VAC therapy will be withdrawn , and follow by delayed primary closure.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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Jalisco
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Guadalajara, Jalisco, Mexico, 44340
- Western Medical Center, Mexican Institute of Social Security
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female patients of 18 years or older
- Diagnosis of Deep Neck Abscess users of the Mexican Institute of Social Security
- Incision from the anterior edge of the SCM muscle to unilateral or bilateral paratracheal line
- Spread of infection to a space larger than 7 cm
- Patients with systemic diseases
Exclusion Criteria:
- Patients with extensive necrosis of tissue that does not allow the suture of the wound
- Patients who for some reason do not conclude the study
- Patients with complications that require taking off the VAC Therapy
- Patients who miss their follow
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: VAC Therapy
active comparator: 14 patients within the first three days the VAC therapy was 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.
|
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.
|
Placebo Comparator: Traditional Therapy
14 patients: 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) .
|
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) .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Granulation tissue percentage
Time Frame: every 3 days up to 3 months
|
the percentage of granulation tissue will be evaluated by a software called image Image J
|
every 3 days up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complications
Time Frame: every 3 days up to 3 months
|
haematoma, and wound dehiscence
|
every 3 days up to 3 months
|
microorganisms
Time Frame: every 7 days up to 3 months
|
culture of the wound secretion
|
every 7 days up to 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality
Time Frame: Up to 6 months
|
deaths registered during the study
|
Up to 6 months
|
Collaborators and Investigators
Investigators
- Study Director: Clotilde Fuentes-Orozco, PhD, Instituto Mexicano del Seguro Social
- Principal Investigator: Luis H Govea-Camacho, PhD, Instituto Mexicano del Seguro Social
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VACOTOL-012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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