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Vacuum Assisted Closure in Neck Abscess

Primary Purpose

Neck Abscess

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
VAC Therapy
TRADITIONAL THERAPY
Sponsored by
Instituto Mexicano del Seguro Social
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Abscess focused on measuring VAC Therapy, Neck Abscess, Traditional Therapy, Wound Healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Western Medical Center, Mexican Institute of Social Security

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

VAC Therapy

Traditional Therapy

Arm Description

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.

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) .

Outcomes

Primary Outcome Measures

Granulation tissue percentage
the percentage of granulation tissue will be evaluated by a software called image Image J

Secondary Outcome Measures

complications
haematoma, and wound dehiscence
microorganisms
culture of the wound secretion

Full Information

First Posted
March 27, 2014
Last Updated
April 21, 2014
Sponsor
Instituto Mexicano del Seguro Social
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1. Study Identification

Unique Protocol Identification Number
NCT02102685
Brief Title
Vacuum Assisted Closure in Neck Abscess
Official Title
Vacuum Assisted Closure in Deep Neck Abscess
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Abscess
Keywords
VAC Therapy, Neck Abscess, Traditional Therapy, Wound Healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VAC Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Traditional Therapy
Arm Type
Placebo Comparator
Arm Description
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) .
Intervention Type
Procedure
Intervention Name(s)
VAC Therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
TRADITIONAL THERAPY
Intervention Description
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) .
Primary Outcome Measure Information:
Title
Granulation tissue percentage
Description
the percentage of granulation tissue will be evaluated by a software called image Image J
Time Frame
every 3 days up to 3 months
Secondary Outcome Measure Information:
Title
complications
Description
haematoma, and wound dehiscence
Time Frame
every 3 days up to 3 months
Title
microorganisms
Description
culture of the wound secretion
Time Frame
every 7 days up to 3 months
Other Pre-specified Outcome Measures:
Title
mortality
Description
deaths registered during the study
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clotilde Fuentes-Orozco, PhD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Luis H Govea-Camacho, PhD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Medical Center, Mexican Institute of Social Security
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico

12. IPD Sharing Statement

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Vacuum Assisted Closure in Neck Abscess

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