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

NCT04053946 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-04-19

No results posted yet for this study

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

Interventions

DEVICE

Next Science Wounds Gels

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

Sponsors & Collaborators

  • University of Maryland, Baltimore

    collaborator OTHER

  • Next Science TM

    lead INDUSTRY

Principal Investigators

  • Khanjan H Nagarsheth, MD, MBA, FACS, RPVI · University of Maryland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2021-10-01
Completion
2021-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04053946 on ClinicalTrials.gov