Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Woun… (NCT04053946) | Clinical Trial Compass
WithdrawnNot Applicable
Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound Compared to SOC
Stopped: Site backed out
0Started 2019-10-01
Plain-language 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 bioburden using combination treatment of Next Science SurgXâ„¢ Antimicrobial Wound Gel and BlastXâ„¢ Antimicrobial Wound Gels as compared to standard of care.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
✕
What they're measuring
1
Percentage of Incisional Wound Area Change
Timeframe: 28 Days
2
Time to when Patient is Ready for Prosthetic Fitting