The purpose of this study was to evaluate the safety and effectiveness of Irrisept compared to standard of care treatment of skin and soft tissue infections in the form of abscesses.
After being informed about the trial and potential risks, subjects completed an informed consent form prior to participation. After eligibility criteria was verified, an initial wound assessment examination was performed. Subjects were then randomized to the Irrisept or Standard of Care treatment group. At intervals of 48 hours (up to 96 hours) later, abscesses were assessed until healing occurred. If the subject required antibiotics, this was recorded, as well as results from the wound and Methicillin-resistant Staphylococcus Aureus (MRSA) cultures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
35
SoC consisted of irrigation with normal saline, using the same proprietary abscess irrigation tip as the Irrisept arm. SoC was used at the initial visit and at each subsequent 48-hour visit interval (up to 96 hours) until abscess healing.
Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression. The device had an option for use with an Irriprobe applicator or an abscess irrigation tip. Irrisept was used at the initial visit and at each subsequent 48-hour visit interval (up to 96 hours) until abscess healing.
University of Florida, Shands Emergency Department
Gainesville, Florida, United States
Number of Subjects That Used Oral Antibiotics
Oral antibiotic use was used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline).
Time frame: 24, 48, 72 & 96-hour visit intervals
Abscess Wound Healing Determined By Wound Improvement Score
Wound improvement assessments were used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline). Wound improvement was assessed via a clinician's discretion, according to a 5-point Likert scale: 1 = clinically resolved, no signs of active infection; 2 = markedly improved, resolving infection and healing; 3 = improved with some remaining signs of active infection; 4 = unchanged, stable without signs of worsening clinical infection and; 5 = worsening conditions. The results are shown using a chi-squared test, as an average Likert score compared between the 2 arms.
Time frame: Abscess wound healing, assessed by wound improvement, was reviewed at the 48-hour visit.
Abscess Wound Healing Determined By Exudation Score
Exudation assessments were used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline). Exudation was assessed via a clinician's discretion, according to a 5-point Likert scale: 1 = none; 2 = scant; 3 = minimal; 4 = moderate and; 5 = copious. The results are shown using a chi-squared test to compare the means at baseline and 48-hours. A two-tailed t-test was conducted for the mean improvement.
Time frame: Abscess wound healing, assessed by exudation, was reviewed at baseline and the 48-hour visit.
Abscess Wound Healing Determined By Pain Score
Pain assessments were used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline). Pain was assessed using a Visual Analogue Scale (VAS). The scale was measured in centimeters (cm) which ranged between 0 cm ("no pain" at the far left) to 9.5 cm ("most severe pain" at the far right). Subjects marked their pain rating on the scale with an "X". The distance from the beginning of the scale (far left) to the "X" was measured in cm. The mean VAS score was assessed at baseline and at the 48-hour follow-up visit. The overall mean improvement was compared between the 2 arms using two-tailed t-tests.
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Time frame: Abscess wound healing, assessed by pain, was reviewed at baseline and the 48-hour visit.
Oral Antibiotic Use Required, Determined By Erythema Area Size
Erythema was assessed to determine if the use of Irrisept reduced or eliminated the need for oral antibiotics in uncomplicated abscesses. The mean circumference of the erythema area, measured in centimeters (cm), was assessed at baseline and 48-hours later. This was performed by the clinician drawing a circle with a marker around the area of redness surrounding the abscess. Mean improvement was compared between the 2 arms using two-tailed t-tests.
Time frame: The need for oral antibiotics, assessed by erythema, was reviewed at baseline and the 48-hour visit.
Oral Antibiotic Use Required, Determined By Induration (Abscess Area Size)
Induration or abscess size was assessed to determine if the use of Irrisept reduced or eliminated the need for oral antibiotics in uncomplicated abscesses. The need for oral antibiotics, assessed by the mean induration or abscess size (measured in cm), was reviewed at baseline and the 48-hour visit. Mean improvement was compared between the 2 arms using two-tailed t-tests.
Time frame: 48-hours after baseline
Oral Antibiotic Use Required Due To Warmth
Warmth was assessed to determine if the use of Irrisept reduced or eliminated the need for oral antibiotics in uncomplicated abscesses. Clinicians recorded whether the abscess was warm for each subject initially and after 48 hours.
Time frame: The need for oral antibiotics, assessed by warmth, was reviewed at baseline and the 48-hour visit.
Oral Antibiotic Use Required Due To Fluctuance
The presence of fluctuance was assessed to determine if the use of Irrisept reduced or eliminated the need for oral antibiotics in uncomplicated abscesses. Clinicians recorded whether fluctuance was present for each subject initially and after 48 hours.
Time frame: The need for oral antibiotics, assessed by fluctuance, was reviewed at baseline and the 48-hour visit.