Vacuum Assisted Closure in Neck Abscess

NCT02102685 | Completed Phase 3 DMC

• 1 other identifier: VACOTOL-012
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Abscess

Keywords

VAC Therapy; Neck Abscess; Traditional Therapy; Wound Healing

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• complications

  every 3 days up to 3 months

• microorganisms

  every 7 days up to 3 months

Other Outcomes (1)

• mortality

  Up to 6 months

Study Arms (2)

VAC Therapy

ACTIVE COMPARATOR

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.

Procedure: VAC Therapy

Traditional Therapy

PLACEBO COMPARATOR

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) .

Procedure: TRADITIONAL THERAPY

Interventions

VAC Therapy PROCEDURE

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.

VAC Therapy

TRADITIONAL THERAPY PROCEDURE

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) .

Traditional Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Western Medical Center, Mexican Institute of Social Security

Guadalajara, Jalisco, 44340, Mexico

Location

Study Officials

• Clotilde Fuentes-Orozco, PhD

  Instituto Mexicano del Seguro Social

  STUDY DIRECTOR

• Luis H Govea-Camacho, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 3, 2014
• Study Start: September 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2013
• Last Updated: April 22, 2014

Record last verified: 2014-04

Locations

ME (1)