The Effect of Wound Irrigation With Irrisept on Abscess Healing (Irrisept UF Study)

NCT04957732 | Terminated Results DMC FDA Device

• 1 other identifier: 20101227
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abscess

Keywords

Wound Irrigation

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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.

  Abscess wound healing, assessed by pain, was reviewed at baseline and the 48-hour visit.

Secondary Outcomes (4)

• Oral Antibiotic Use Required, Determined By Erythema Area Size

  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)

  48-hours after baseline

• Oral Antibiotic Use Required Due To Warmth

  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 need for oral antibiotics, assessed by fluctuance, was reviewed at baseline and the 48-hour visit.

Other Outcomes (1)

• Oral Antibiotic Use Required Due To Results of MRSA/Wound Culture

  0 days

Study Arms (2)

Standard of Care (SoC)

ACTIVE COMPARATOR

For subjects randomized to the control group, Standard of Care (SoC), which was normal saline, was used.

Device: Standard of Care (SoC)

Irrisept

ACTIVE COMPARATOR

For subjects randomized to the investigational group, Irrisept was used.

Device: Irrisept Delivery System

Interventions

Standard of Care (SoC) DEVICE

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.

Standard of Care (SoC)

Irrisept Delivery System DEVICE

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.

Also known as: Irrisept

Irrisept

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Immunocompetent individuals, 12 years of age or older with an uncomplicated abscess
• Uncomplicated abscess is defined as ≤8 cm of induration (defined as firmness to touch) at the greatest diameter.
• ≤4 cm of surrounding erythema (surrounding redness).
• Defined area of central fluctuance may or may not be present.
• Patient must be able to answer questions.
• Patient must be medically stable as defined by the emergency department physician.
• Patient must participate voluntarily in the study.

You may not qualify if:

• Currently receiving antibiotics or received antibiotics within the last 72 hours.
• Evidence of systemic infection (fever, aches, chills, nausea).
• Requires admission to the hospital for infection or for any other reason(s).
• Abscess caused by a human or animal bite.
• Prior history of hypersensitivity or allergy to Chlorhexidine Gluconate (CHG).
• Immunodeficiency (examples: HIV positive, Crohn's disease, systemic lupus erythematosus, Addison's disease, psoriasis, splenectomy, leukemia, cancer (on chemotherapy)).
• Currently on any immune-modifying medication (examples - prednisone, antivirals).
• History of chronic skin infection (3 or more in the past year).
• Chronic medical problem (for example, end-stage heart, liver, kidney or lung disease, diabetes mellitus, peripheral vascular disease, history of organ transplant).
• Mental illness, including but not limited to, substance abuse, dementia, schizophrenia or mentally handicapped or challenged.
• Incarcerated.
• Patient is pregnant or thinks she may be pregnant.

Sponsors & Collaborators

• Irrimax Corporation: lead

Study Sites (1)

University of Florida, Shands Emergency Department

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Abscess

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Richard Petrik, MD, Clinical Assistant Professor
• Organization: University of Florida Shands Emergency Department

352-265-5911

Study Officials

• Richard Petrik, MD

  University of Florida/Shands Emergency Department

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The randomization methodology was controlled by the site.

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 12, 2021
• Study Start: January 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 2, 2022
• Results First Posted: February 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)