Status:
WITHDRAWN
Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound Compared to SOC
Lead Sponsor:
Next Science TM
Collaborating Sponsors:
University of Maryland, Baltimore
Conditions:
Surgical Wound
Surgical Site Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 bio...
Detailed Description
This is a prospective, randomized, 90 day, open-label study of patients undergoing below the knee amputation (BKA) with primary closure or completion. Patients who present for BKA with primary closur...
Eligibility Criteria
Inclusion
- Male or non-pregnant female 18 years or older
- Participant must be undergoing below the knee amputation with primary closure or completion below the knee amputation with primary closure.
- There must be no infection present at the surgical incision site
- Participant is determined to NOT require endovascular or vascular reconstructive surgery to restore blood flow to the wound within the study period
- 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
- No known allergic reaction or sensitivity to investigational product or components
- 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
- Provide signed and dated informed consent
Exclusion
- Male or Female less than 18 years old
- 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)
- Systemic sepsis at the time of surgery
- Disseminated Cancer Patients
- Current long-term (more than 30 consecutive days) use of moderate or high dose oral corticosteroids
- Current long-term (more than 30 consecutive days) use of immune modulators/suppressors
- Known sensitivity to investigational product or any components
- Participants with HIV or acquired immunodeficiency syndrome (AIDS) or any other immunodeficient states
- Any disease or prior/planned surgery or other situation that in the investigator's opinion may interfere with the participant successfully completing the study.
- Overlapping participation in another treatment or interventional clinical trial.
- Family members or students of the Investigator or clinical site.
- 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.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04053946
Start Date
October 1 2019
End Date
October 1 2021
Last Update
April 19 2023
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