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Suboptimal Recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (SoC) | Active Comparator | For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s). |
|
| Irrisept | Active Comparator | For subjects randomized to the investigational group, Irrisept was used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care (SoC) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Wein, MD | Tampa General Hospital, University South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Hospital - University of South Florida | Tampa | Florida | 33606 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care (SoC) | The type of irrigation solution and method used as SoC was determined by the participating emergency department physician. The SoC method was used at the initial and 48-hour follow-up visit. |
| FG001 | Irrisept Delivery System | Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits. 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. |
| FG002 | Randomization Unknown | The randomization group (SoC or Irrisept) is unknown for 1 subject. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 114 subjects were consented. There were 6 screen failures. There were 107 subjects randomized (55 to Irrisept and 52 to SoC). One (1) subject had no randomization information available. There were 52 Irrisept and 45 SoC subjects that completed the trial. For one SoC subject, the gender is unknown.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 48 hours |
|
The timeframe used for reporting adverse events was from the time of informed consent until subject termination or completion (approximately 48 hours after the initial visit).
Any change in the subjects' wound infection (i.e. any worsening of the secondary objective clinical outcomes) were considered adverse events. Causality assessments were provided. All-cause mortality and serious adverse events were not monitored nor assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care (SoC) | The type of irrigation solution and method used as SoC was determined by the participating emergency department physician. The SoC method was used at the initial and 48-hour follow-up visit. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Length | Infections and infestations | Non-systematic Assessment | Change in length, measured in cm. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chevy Brown, Clinical Trials Manager | Irrimax Corporation | 770-807-3355 | 15 | chevy.brown@irrisept.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2010 | Jun 11, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018461 | Soft Tissue Infections |
| D000038 | Abscess |
| ID | Term |
|---|---|
| D007239 | Infections |
| D013492 | Suppuration |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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The randomization methodology was controlled by a biostatistician at the site.
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|
| 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. Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits. |
|
|
| 48 hours |
| BG001 | 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. |
| BG002 | Randomization Unknown |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | There were 52 Irrisept and 45 SoC subjects that completed the trial. For one SoC subject, the gender is unknown. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | Randomization Unknown |
|
|
| 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. | 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. | Posted | Number | Total Number of Worsening Outcomes | 48 hours | Total Number of Worsening Outcomes | Total Number of Worsening Outcomes |
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|
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| Post-Hoc | Worsening Events Causality | Causality for each worsening event was determined by using the following categories: 'related', 'possibly related', 'unlikely related', or 'unrelated'. | 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. | Posted | Count of Units | Total Number of Worsening Outcomes | 48 Hours | Total Number of Worsening Outcomes | Total Number of Worsening Outcomes |
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|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 20 |
| 45 |
| EG001 | Irrisept Delivery System | Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits. 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. | 0 | 0 | 0 | 0 | 16 | 52 |
| EG002 | Randomization Unknown | There are records of an additional subject completing the study, but no randomization information was available. | 0 | 0 | 0 | 0 | 1 | 1 |
|
| Increased Width | Infections and infestations | Non-systematic Assessment | Change in width, measured in cm. |
|
| Erythema | Infections and infestations | Non-systematic Assessment |
|
| Area | Infections and infestations | Non-systematic Assessment | Area, measured in cm2. |
|
| Induration | Infections and infestations | Non-systematic Assessment |
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| Tenderness | Infections and infestations | Non-systematic Assessment |
|
| Warmth | Infections and infestations | Non-systematic Assessment |
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| Pain | Infections and infestations | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | Non-systematic Assessment |
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| Other | Infections and infestations | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
|
| Erythema |
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| Area (cm2) |
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| Induration |
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| Tenderness |
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| Warmth |
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| Pain |
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| Cellulitis |
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| Other |
|
| No Signs of Infection Worsening |
|
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| Unlikely Related Worsening Event |
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| Unrelated Worsening Event |
|