Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound Compared to SOC

NCT04053946 | Withdrawn

• 1 other identifier: CSP-012
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 bioburden using combination treatment of Next Science SurgX™ Antimicrobial Wound Gel and BlastX™ Antimicrobial Wound Gels as compared to standard of care.

Conditions

Surgical Wound; Surgical Site Infection; Surgical Wound Infection; Amputation Stump; Infection; Surgical Incision

Keywords

BKA; biofilm; Next Science

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Bioburden

  Day 0, Day 14, Day 28

• Bioburden

  Day 0, Day 14, Day 28

• Bioburden

  Day 0, Day 14, Day 28

• Wound Area Reduction

  Baseline to 21 days

Study Arms (2)

Next Science

EXPERIMENTAL

Following amputation, SurgX™ will be applied directly to the surgical incision in the operating room under sterile conditions and covered with SOC dressing. The surgical dressing will not be removed until post-operative day 3, except if deemed necessary by the treating surgeon. At that time, direct application of the BlastX™ to the incision will be placed, then covered with a SOC dressing. BlastX™ will be applied every day and covered with SOC dressing.

Device: Next Science Wounds Gels

Control

NO INTERVENTION

Post-op SOC dressing as per treating research doctor to include dressing changes post-op day 3 and daily thereafter.

Interventions

Next Science Wounds Gels DEVICE

SurgX will be applied once at closure while BlastX will be applied everyday until day 28 with each dressing change.

Next Science

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Next Science TM: lead
• University of Maryland, Baltimore: collaborator

MeSH Terms

Conditions

Surgical Wound; Surgical Wound Infection; Infections

Condition Hierarchy (Ancestors)

Wounds and Injuries; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Khanjan H Nagarsheth, MD, MBA, FACS, RPVI

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 13, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share