Neck Abscess Clinical Trial
Official title:
Vacuum Assisted Closure in Deep Neck Abscess
Verified date | April 2014 |
Source | Instituto Mexicano del Seguro Social |
Contact | n/a |
Is FDA regulated | No |
Health authority | Mexico: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | September 2013 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | Western Medical Center, Mexican Institute of Social Security | Guadalajara | Jalisco |
Lead Sponsor | Collaborator |
---|---|
Instituto Mexicano del Seguro Social |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | mortality | deaths registered during the study | Up to 6 months | Yes |
Primary | Granulation tissue percentage | the percentage of granulation tissue will be evaluated by a software called image Image J | every 3 days up to 3 months | Yes |
Secondary | complications | haematoma, and wound dehiscence | every 3 days up to 3 months | Yes |
Secondary | microorganisms | culture of the wound secretion | every 7 days up to 3 months | Yes |
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