Surgical Site Infection Clinical Trial
Official title:
Clinical Assessment of the Next Science BlastXTM Antimicrobial Gel and SurgXTM Antimicrobial Gel Healing Efficacy for Below the Knee Amputation Surgical Wound Compared to Standard of Care
NCT number | NCT04053946 |
Other study ID # | CSP-012 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2019 |
Est. completion date | October 1, 2021 |
Verified date | April 2023 |
Source | Next Science TM |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a 64-patient, 90-day, open -label study on adult patients undergoing below knee amputation for various etiologies. The objective of this study is to assess surgical wound healing and wound bioburden using combination treatment of Next Science SurgX™ Antimicrobial Wound Gel and BlastX™ Antimicrobial Wound Gels as compared to standard of care.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 1, 2021 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Male or non-pregnant female 18 years or older 2. Participant must be undergoing below the knee amputation with primary closure or completion below the knee amputation with primary closure. 3. There must be no infection present at the surgical incision site 4. Participant is determined to NOT require endovascular or vascular reconstructive surgery to restore blood flow to the wound within the study period 5. Must have a popliteal pressure on arterial doppler of 40 mm Hg or higher in the surgical leg or angiographic evidence of popliteal artery flow 6. No known allergic reaction or sensitivity to investigational product or components 7. Willing and able to comply with all study procedures including transportation to the study site for all scheduled visits and be available for the duration of the study 8. Provide signed and dated informed consent Exclusion Criteria: 1. Male or Female less than 18 years old 2. Pregnancy as determined by pre-op urine hCG testing on the day of surgery for women of childbearing potential (women are considered clinically post-menopausal if over 12 consecutive months without a menstrual period) 3. Systemic sepsis at the time of surgery 4. Disseminated Cancer Patients 5. Current long-term (more than 30 consecutive days) use of moderate or high dose oral corticosteroids 6. Current long-term (more than 30 consecutive days) use of immune modulators/suppressors 7. Known sensitivity to investigational product or any components 8. Participants with HIV or acquired immunodeficiency syndrome (AIDS) or any other immunodeficient states 9. Any disease or prior/planned surgery or other situation that in the investigator's opinion may interfere with the participant successfully completing the study. 10. Overlapping participation in another treatment or interventional clinical trial. 11. Family members or students of the Investigator or clinical site. 12. Safety exclusion criterion: At the end of the procedure, the surgeon and PI can discuss to withdraw the patient, if it is felt that continuing in the study will be detrimental to the patient. For example, if the incision cannot be closed, or if it requires a muscle flap, or if the incision site encounters contamination or infection not recognized prior to the start of surgery. The decision to withdraw the patient will be made in the OR, prior to being randomized. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Next Science TM | University of Maryland, Baltimore |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Incisional Wound Area Change | Incisional wounds treated with SurgX™, BlastX™ and SOC Treatment will have higher percentage of area reduction than SOC alone after 28 days of treatment. | 28 Days | |
Primary | Time to when Patient is Ready for Prosthetic Fitting | Participants treated with SurgX™, BlastX™ and SOC treatment will be deemed ready to be fitted with a prosthetic limb earlier (days) than those in the SOC Control Group. | Day 0 to 90 Days | |
Secondary | Bioburden | The amount of viable microorganisms persisting in wounds (CFU) treated with SurgX™, BlastX™ and SOC treatment will be less than those in the SOC Control Group at one or more of the measured time points. | Day 0, Day 14, Day 28 | |
Secondary | Bioburden | The semi-quantitative amount of DNA measured microorganisms persisting in wounds treated with SurgX™, BlastX™ and SOC will be less when compared to the SOC Control Group at one or more of the measured time points. | Day 0, Day 14, Day 28 | |
Secondary | Bioburden | The number of DNA measured microorganisms persisting in wounds treated with SurgX™, BlastX™ and SOC treatment will be less when compared to the SOC Control Group at one or more of the measured time points. | Day 0, Day 14, Day 28 | |
Secondary | Wound Area Reduction | Percentage of surgical wound area change after treatment with SurgX™ at the time of the procedure plus 14 and 21 days of treatment with BlastX™ wound gel compared to SOC. | Baseline to 21 days |
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