An interventional study of Standard of Care (SoC) and Irrisept Delivery System in Skin and Soft Tissue Infections and Abscess, sponsored by Irrimax Corporation. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-08-23.
Sponsored by Irrimax Corporation · Not applicable, Interventional, and Other
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.
96 studies on the registry are indexed under Soft Tissue Infections; 13 are open to participants now.
This study's enrollment of 114 is close to the median of 120 across 61 interventional studies indexed under Soft Tissue Infections.
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Exclusion Criteria:
For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s).
Device: Standard of Care (SoC)
For subjects randomized to the investigational group, Irrisept was used.
Device: Irrisept Delivery System
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.
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.
Also known as: Irrisept
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
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
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.
| Milestone | Standard of Care (SoC) | Irrisept Delivery System | Randomization Unknown |
|---|---|---|---|
| Started | 52 | 55 | 1 |
| Completed | 45 | 52 | 1 |
| Not completed | 7 | 3 | 0 |
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.
| Participants | Standard of Care (SoC) | Irrisept Device System | Randomization Unknown |
|---|---|---|---|
| Improved Wound State at 48-Hour Follow-up | 40 | 47 | 0 |
| No Change Wound State at 48-Hour Follow-up | 1 | 1 | 0 |
| Progression Wound State at 48-Hour Follow-up | 3 | 2 | 0 |
| Immediate Treatment Required Wound State at 48-Hour Follow-up | 1 | 2 | 1 |
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.
| Total Number of Worsening Outcomes | Standard of Care (SoC) | Irrisept Delivery System | Randomization Unknown |
|---|---|---|---|
| Increased Length (cm) | 5 | 9 | 0 |
| Increased Width (cm) | 3 | 5 | 1 |
| Erythema | 4 | 0 | 0 |
| Area (cm2) | 1 | 3 | 0 |
| Induration | 6 | 2 | 0 |
| Tenderness | 2 | 2 | 0 |
| Warmth | 6 | 3 | 0 |
| Pain | 3 | 3 | 0 |
| Cellulitis | 0 | 0 | 0 |
| Other | 2 | 1 | 0 |
| No Signs of Infection Worsening | 25 | 36 | 0 |
Causality for each worsening event was determined by using the following categories: 'related', 'possibly related', 'unlikely related', or 'unrelated'.
| Total Number of Worsening Outcomes | Standard of Care (SoC) | Irrisept Delivery System | Randomization Unknown |
|---|---|---|---|
| Related Worsening Event | 0 | 0 | 0 |
| Possibly Related Worsening Event | 0 | 0 | 0 |
| Unlikely Related Worsening Event | 28 | 26 | 0 |
| Unrelated Worsening Event | 4 | 2 | 1 |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care (SoC) | — | — | 20/45 (44.4%) |
| Irrisept Delivery System | — | — | 16/52 (30.8%) |
| Randomization Unknown | — | — | 1/1 (100%) |
| Event | Standard of Care (SoC) | Irrisept Delivery System | Randomization Unknown |
|---|---|---|---|
| Increased WidthInfections and infestations | 3/45 | 5/52 | 1/1 |
| Increased LengthInfections and infestations | 5/45 | 9/52 | 0/1 |
| IndurationInfections and infestations | 6/45 | 2/52 | 0/1 |
| WarmthInfections and infestations | 6/45 | 3/52 | 0/1 |
| ErythemaInfections and infestations | 4/45 | 0/52 | 0/1 |
| PainInfections and infestations | 3/45 | 3/52 | 0/1 |
| AreaInfections and infestations | 1/45 | 3/52 | 0/1 |
| TendernessInfections and infestations | 2/45 | 2/52 | 0/1 |
| OtherInfections and infestations | 2/45 | 1/52 | 0/1 |
| CellulitisInfections and infestations | 0/45 | 0/52 | 0/1 |
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.
| Age, Customized(Participants) | Standard of Care (SoC) | Irrisept Device System | Randomization Unknown | Total |
|---|---|---|---|---|
| Subject Accounting | 45 | 52 | 1 | 98 |
| Sex/Gender, Customized(Participants) | Standard of Care (SoC) | Irrisept Device System | Randomization Unknown | Total |
|---|---|---|---|---|
| Gender — Female | 25 | 27 | 0 | 52 |
| Gender — Male | 19 | 25 | 1 | 45 |
| Gender — Unknown Gender | 1 | 0 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Standard of Care (SoC) | Irrisept Device System | Randomization Unknown | Total |
|---|---|---|---|---|
| Race (Black) | 15 | 25 | 0 | 40 |
| Race (White) | 23 | 18 | 1 | 42 |
| Ethnicity (Hispanic) | 6 | 7 | 0 | 13 |
| Unknown Race/Ethnicity | 1 | 2 | 0 | 3 |
| Region of Enrollment(Participants) | Standard of Care (SoC) | Irrisept Device System | Randomization Unknown | Total |
|---|---|---|---|---|
| United States | 45 | 52 | 1 | 98 |
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