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Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging.

NCT07004764 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-03-31

No results posted yet for this study

Summary

Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Feasibility Study on Nitropaste Using Intraoperative SPY Imaging.

Conditions

  • Achilles Tendon Repairs/Reconstructions
  • Pilon Fracture of Tibia
  • Tibial Plateau Fracture
  • Ankle Fracture (Bimalleolar Equivalent, Bimalleolar, or Trimalleolar)
  • Calcaneus Fractures
  • Talus Fracture
  • Wound Infection Deep
  • Wound Infection Post-Traumatic
  • Wound Dehiscence, Surgical

Interventions

DRUG

Nitroglycerin Ointment 2%

Patients will have pre- and post-nitropaste tissue perfusion measurement with the LA-ICG system.

Sponsors & Collaborators

Principal Investigators

  • Henry T Shu, MD · Johns Hopkins University

  • Babar Shafi, MD, MSPT · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2027-09-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT07004764 on ClinicalTrials.gov