Abscess, Skin and Soft Tissue Infections
Conditions
Brief summary
The purpose of this study was to determine whether Irrisept can effectively prevent the progression of skin and soft tissue infections (SSTIs) as compared to treatment by the current Standard of Care.
Detailed description
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. Forty-eight hours later, wound progression and signs of infection were assessed.
Interventions
DEVICEStandard of Care (SoC)
The preferred irrigation solution and method was chosen by the site's emergency department physician(s) and could vary between subjects. The type of SoC was recorded in the source document and the same solution and irrigation method were used during the initial treatment and 48-hour follow-up visits.
DEVICEIrrisept Delivery System
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. Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits.
Sponsors
Irrimax Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The randomization methodology was controlled by a biostatistician at the site.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 80 2. Skin and soft tissue infections (SSTIs), in the form of an abscess, which will require incision and drainage. 3. Patient able to provide an informed consent. 4. Patient volunteers to participate.
Exclusion criteria
1. Wound was caused by human or animal bite. 2. Wound is a blunt crush injury or has tendon, bone, or joint involvement. 3. Diabetic foot infection. 4. Anticipated incision size less than 5mm. 5. Abscess extends to the muscle layer. 6. Admission to hospital for any reason, including IV antibiotics. 7. Clinical signs of systemic infection on initial patient encounter. 8. Prior history of allergy or hypersensitivity to CHG. 9. Neutropenic (known ANC\<500/mm3), HIV (known CD4\<50), or other severely immunocompromised state (e.g., receiving chemotherapy). 10. Patient is diagnosed with systemic lupus erythematosus or other immunological disease. 11. Currently in police custody. 12. Patient withdraws from participation. 13. Patient unable or unwilling to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound State at 48-Hour Follow-up Visit | 48 hours | The primary endpoint was overall wound progression and signs of infection 48 hours post-treatment. This was measured via a blinded investigator's discretion and recorded as 'improved', 'no change', 'progression of signs or symptoms of infection', or 'immediate treatment required' if an infection had progressed to a certain extent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Performance of Irrisept to the Current SoC | 48 hours | The study tracked any instance of a subject's conditions worsening compared to their baseline measurements. This included a worsening in the size (length and width) and clinical signs (erythema, area, induration, tenderness, warm, pain, cellulitis and other) of the infection. While the protocol states the overall prevalence of Methicillin-resistant Staphylococcus Aureus (MRSA) colonization is the secondary objective, this information was not collected by the site. Therefore, worsening of clinical outcomes is considered the secondary objective. |
Countries
United States
Participant flow
Recruitment details
From January 2010 to December 2011, patients with skin and soft tissue infections were recruited from the Tampa General Hospital, University of South Florida emergency department.
Pre-assignment details
A total of 114 subjects consented to the study. Of these, 107 subjects were randomized as six (6) failed screening and one (1) subject had no randomization information available, but still completed the study. In total, 98 subjects completed the study. Of those 98 subjects, 52 subjects were enrolled in the Irrisept arm and 45 subjects were enrolled in the SoC control arm. There are records of an additional subject completing the study, but no randomization information was available.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care (SoC) For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s).
Standard of Care (SoC): The preferred irrigation solution and method was chosen by the site's emergency department physician(s) and could vary between subjects. The type of SoC was recorded in the source document and the same solution and irrigation method were used during the initial treatment and 48-hour follow-up visits. | 45 |
| Irrisept Device System For subjects randomized to the investigational group, Irrisept was used.
Irrisept Delivery System: 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.
Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits. | 52 |
| Randomization Unknown | 1 |
| Total | 98 |
Baseline characteristics
| Characteristic | Standard of Care (SoC) | Irrisept Device System | Randomization Unknown | Total |
|---|---|---|---|---|
| Age, Customized Subject Accounting | 45 Participants | 52 Participants | 1 Participants | 98 Participants |
| Race/Ethnicity, Customized Ethnicity (Hispanic) | 6 Participants | 7 Participants | 0 Participants | 13 Participants |
| Race/Ethnicity, Customized Race (Black) | 15 Participants | 25 Participants | 0 Participants | 40 Participants |
| Race/Ethnicity, Customized Race (White) | 23 Participants | 18 Participants | 1 Participants | 42 Participants |
| Race/Ethnicity, Customized Unknown Race/Ethnicity | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Region of Enrollment United States | 45 Participants | 52 Participants | 1 Participants | 98 Participants |
| Sex/Gender, Customized Gender Female | 25 Participants | 27 Participants | 0 Participants | 52 Participants |
| Sex/Gender, Customized Gender Male | 19 Participants | 25 Participants | 1 Participants | 45 Participants |
| Sex/Gender, Customized Gender Unknown Gender | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 20 / 45 | 16 / 52 | 1 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Wound State at 48-Hour Follow-up Visit
The primary endpoint was overall wound progression and signs of infection 48 hours post-treatment. This was measured via a blinded investigator's discretion and recorded as 'improved', 'no change', 'progression of signs or symptoms of infection', or 'immediate treatment required' if an infection had progressed to a certain extent.
Time frame: 48 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care (SoC) | Wound State at 48-Hour Follow-up Visit | Improved Wound State at 48-Hour Follow-up | 40 Participants |
| Standard of Care (SoC) | Wound State at 48-Hour Follow-up Visit | Progression Wound State at 48-Hour Follow-up | 3 Participants |
| Standard of Care (SoC) | Wound State at 48-Hour Follow-up Visit | No Change Wound State at 48-Hour Follow-up | 1 Participants |
| Standard of Care (SoC) | Wound State at 48-Hour Follow-up Visit | Immediate Treatment Required Wound State at 48-Hour Follow-up | 1 Participants |
| Irrisept Device System | Wound State at 48-Hour Follow-up Visit | Improved Wound State at 48-Hour Follow-up | 47 Participants |
| Irrisept Device System | Wound State at 48-Hour Follow-up Visit | Immediate Treatment Required Wound State at 48-Hour Follow-up | 2 Participants |
| Irrisept Device System | Wound State at 48-Hour Follow-up Visit | Progression Wound State at 48-Hour Follow-up | 2 Participants |
| Irrisept Device System | Wound State at 48-Hour Follow-up Visit | No Change Wound State at 48-Hour Follow-up | 1 Participants |
| Randomization Unknown | Wound State at 48-Hour Follow-up Visit | Immediate Treatment Required Wound State at 48-Hour Follow-up | 1 Participants |
| Randomization Unknown | Wound State at 48-Hour Follow-up Visit | Progression Wound State at 48-Hour Follow-up | 0 Participants |
| Randomization Unknown | Wound State at 48-Hour Follow-up Visit | No Change Wound State at 48-Hour Follow-up | 0 Participants |
| Randomization Unknown | Wound State at 48-Hour Follow-up Visit | Improved Wound State at 48-Hour Follow-up | 0 Participants |
Secondary
Clinical Performance of Irrisept to the Current SoC
The study tracked any instance of a subject's conditions worsening compared to their baseline measurements. This included a worsening in the size (length and width) and clinical signs (erythema, area, induration, tenderness, warm, pain, cellulitis and other) of the infection. While the protocol states the overall prevalence of Methicillin-resistant Staphylococcus Aureus (MRSA) colonization is the secondary objective, this information was not collected by the site. Therefore, worsening of clinical outcomes is considered the secondary objective.
Time frame: 48 hours
Population: There were 45 SoC \& 52 Irrisept subjects that completed the trial. Of these, 20 SoC \& 16 Irrisept subjects showed clinical signs of infection worsening; 25 SoC \& 36 Irrisept subjects did not show infection worsening signs. Worsening signs include changes in length, width, erythema, area, induration tenderness, warmth, pain, cellulitis and other. The total number of worsening signs for SoC subjects was 32. The total number of worsening signs for Irrisept subjects was 28.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Clinical Performance of Irrisept to the Current SoC | Erythema | 4 Total Number of Worsening Outcomes |
| Standard of Care (SoC) | Clinical Performance of Irrisept to the Current SoC | Increased Length (cm) | 5 Total Number of Worsening Outcomes |
| Standard of Care (SoC) | Clinical Performance of Irrisept to the Current SoC | Increased Width (cm) | 3 Total Number of Worsening Outcomes |
| Standard of Care (SoC) | Clinical Performance of Irrisept to the Current SoC | Area (cm2) | 1 Total Number of Worsening Outcomes |
| Standard of Care (SoC) | Clinical Performance of Irrisept to the Current SoC | Induration | 6 Total Number of Worsening Outcomes |
| Standard of Care (SoC) | Clinical Performance of Irrisept to the Current SoC | Tenderness | 2 Total Number of Worsening Outcomes |
| Standard of Care (SoC) | Clinical Performance of Irrisept to the Current SoC | Warmth | 6 Total Number of Worsening Outcomes |
| Standard of Care (SoC) | Clinical Performance of Irrisept to the Current SoC | Pain | 3 Total Number of Worsening Outcomes |
| Standard of Care (SoC) | Clinical Performance of Irrisept to the Current SoC | Cellulitis | 0 Total Number of Worsening Outcomes |
| Standard of Care (SoC) | Clinical Performance of Irrisept to the Current SoC | Other | 2 Total Number of Worsening Outcomes |
| Standard of Care (SoC) | Clinical Performance of Irrisept to the Current SoC | No Signs of Infection Worsening | 25 Total Number of Worsening Outcomes |
| Irrisept Device System | Clinical Performance of Irrisept to the Current SoC | Other | 1 Total Number of Worsening Outcomes |
| Irrisept Device System | Clinical Performance of Irrisept to the Current SoC | Tenderness | 2 Total Number of Worsening Outcomes |
| Irrisept Device System | Clinical Performance of Irrisept to the Current SoC | Warmth | 3 Total Number of Worsening Outcomes |
| Irrisept Device System | Clinical Performance of Irrisept to the Current SoC | No Signs of Infection Worsening | 36 Total Number of Worsening Outcomes |
| Irrisept Device System | Clinical Performance of Irrisept to the Current SoC | Pain | 3 Total Number of Worsening Outcomes |
| Irrisept Device System | Clinical Performance of Irrisept to the Current SoC | Erythema | 0 Total Number of Worsening Outcomes |
| Irrisept Device System | Clinical Performance of Irrisept to the Current SoC | Cellulitis | 0 Total Number of Worsening Outcomes |
| Irrisept Device System | Clinical Performance of Irrisept to the Current SoC | Increased Length (cm) | 9 Total Number of Worsening Outcomes |
| Irrisept Device System | Clinical Performance of Irrisept to the Current SoC | Increased Width (cm) | 5 Total Number of Worsening Outcomes |
| Irrisept Device System | Clinical Performance of Irrisept to the Current SoC | Area (cm2) | 3 Total Number of Worsening Outcomes |
| Irrisept Device System | Clinical Performance of Irrisept to the Current SoC | Induration | 2 Total Number of Worsening Outcomes |
| Randomization Unknown | Clinical Performance of Irrisept to the Current SoC | Area (cm2) | 0 Total Number of Worsening Outcomes |
| Randomization Unknown | Clinical Performance of Irrisept to the Current SoC | Induration | 0 Total Number of Worsening Outcomes |
| Randomization Unknown | Clinical Performance of Irrisept to the Current SoC | Other | 0 Total Number of Worsening Outcomes |
| Randomization Unknown | Clinical Performance of Irrisept to the Current SoC | Increased Width (cm) | 1 Total Number of Worsening Outcomes |
| Randomization Unknown | Clinical Performance of Irrisept to the Current SoC | Tenderness | 0 Total Number of Worsening Outcomes |
| Randomization Unknown | Clinical Performance of Irrisept to the Current SoC | No Signs of Infection Worsening | 0 Total Number of Worsening Outcomes |
| Randomization Unknown | Clinical Performance of Irrisept to the Current SoC | Erythema | 0 Total Number of Worsening Outcomes |
| Randomization Unknown | Clinical Performance of Irrisept to the Current SoC | Warmth | 0 Total Number of Worsening Outcomes |
| Randomization Unknown | Clinical Performance of Irrisept to the Current SoC | Increased Length (cm) | 0 Total Number of Worsening Outcomes |
| Randomization Unknown | Clinical Performance of Irrisept to the Current SoC | Cellulitis | 0 Total Number of Worsening Outcomes |
| Randomization Unknown | Clinical Performance of Irrisept to the Current SoC | Pain | 0 Total Number of Worsening Outcomes |
Post Hoc
Worsening Events Causality
Causality for each worsening event was determined by using the following categories: 'related', 'possibly related', 'unlikely related', or 'unrelated'.
Time frame: 48 Hours
Population: Causality assessment categories for each worsening sign were related, possibly related, unlikely related, or unrelated. 45 SoC and 52 Irrisept subjects completed the trial. Of these, 20 SoC \& 16 Irrisept subjects showed clinical signs of worsening; causality assessments were made for each worsening sign (ex: length, erythema, etc.). There were 32 and 28 total worsening signs for SoC \& Irrisept subjects, respectively.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Standard of Care (SoC) | Worsening Events Causality | Related Worsening Event | 0 Total Number of Worsening Outcomes |
| Standard of Care (SoC) | Worsening Events Causality | Unlikely Related Worsening Event | 28 Total Number of Worsening Outcomes |
| Standard of Care (SoC) | Worsening Events Causality | Possibly Related Worsening Event | 0 Total Number of Worsening Outcomes |
| Standard of Care (SoC) | Worsening Events Causality | Unrelated Worsening Event | 4 Total Number of Worsening Outcomes |
| Irrisept Device System | Worsening Events Causality | Unlikely Related Worsening Event | 26 Total Number of Worsening Outcomes |
| Irrisept Device System | Worsening Events Causality | Possibly Related Worsening Event | 0 Total Number of Worsening Outcomes |
| Irrisept Device System | Worsening Events Causality | Related Worsening Event | 0 Total Number of Worsening Outcomes |
| Irrisept Device System | Worsening Events Causality | Unrelated Worsening Event | 2 Total Number of Worsening Outcomes |
| Randomization Unknown | Worsening Events Causality | Unlikely Related Worsening Event | 0 Total Number of Worsening Outcomes |
| Randomization Unknown | Worsening Events Causality | Related Worsening Event | 0 Total Number of Worsening Outcomes |
| Randomization Unknown | Worsening Events Causality | Possibly Related Worsening Event | 0 Total Number of Worsening Outcomes |
| Randomization Unknown | Worsening Events Causality | Unrelated Worsening Event | 1 Total Number of Worsening Outcomes |