Abscess Clinical Trial
Official title:
Evaluation of a Novel Solution, IrriSept, a New Delivery System, Containing a Long-acting Antimicrobial Agent for Irrigation of Skin and Soft Tissue Infections, in the Form of an Abscess in the Emergency Department: a Pilot Study
NCT number | NCT01076049 |
Other study ID # | 108527 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2010 |
Est. completion date | December 2011 |
Verified date | August 2021 |
Source | Irrimax Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 114 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Tampa General Hospital - University of South Florida | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Irrimax Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 48 hours | |
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. |
48 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03127371 -
Adjunctive Nitrous Oxide During ED Incision and Drainage of Abscess
|
N/A | |
Completed |
NCT02240498 -
Safety and Feasibility Study of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities
|
Phase 1 | |
Completed |
NCT00746109 -
Study of Wound Packing After Superficial Skin Abscess Drainage
|
Phase 4 | |
Completed |
NCT00402727 -
Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection
|
Phase 3 | |
Completed |
NCT00352612 -
Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections
|
Phase 4 | |
Completed |
NCT00137085 -
Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation
|
N/A | |
Completed |
NCT02714023 -
Water And Saline Head-to-head In The Blinded Evaluation Study Trial
|
N/A | |
Completed |
NCT02264392 -
US Guided Versus BlindI&D for Treatment of Soft Tissue Abscesses in the ED
|
N/A | |
Active, not recruiting |
NCT05226260 -
Decreasing Antibiotic Duration for Skin and Soft Tissue Infection Using Behavioral Economics in Primary Care
|
N/A | |
Withdrawn |
NCT04241471 -
Incision and Loop Drainage Utilizing a Novel Technique for Management of Cutaneous Abscess in an Adult Population
|
N/A | |
Recruiting |
NCT06284473 -
Ketamine as a Supplement to Local Anesthesia for Minor Procedures
|
Phase 4 | |
Completed |
NCT01235546 -
Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection
|
N/A | |
Withdrawn |
NCT00900510 -
Antibiotic Therapy After Incision and Drainage for Abscess
|
N/A | |
Not yet recruiting |
NCT03917134 -
Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess After Laparoscopic Hysterectomy
|
N/A | |
Withdrawn |
NCT02703233 -
Effectiveness of Nitrous Oxide in the ED
|
Phase 4 | |
Completed |
NCT01557426 -
Soft Tissue Ultrasound of Infections
|
Phase 1 | |
Completed |
NCT01339091 -
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
|
Phase 3 | |
Completed |
NCT01784458 -
Clinical Significance of Intra-abdominal Hypertension in Surgical Patients With Severe Sepsis
|
N/A | |
Terminated |
NCT00867789 -
Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department
|
N/A | |
Completed |
NCT00984022 -
Aquacel Versus Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage
|
Phase 2 |