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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07004764
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nitroglycerin Ointment 2% — DRUG
    Patients will have pre- and post-nitropaste tissue perfusion measurement with the LA-ICG system.

Study Details

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

Key Dates

Start date
Nov 30, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nitropaste
    All patients enrolled in this study will receive a baseline perfusion measurement with the LA-ICG system. This will occur after wound closure. Subsequently, all patients will receive a single dose of nitropaste intraoperatively and a final LA-ICG tissue perfusion measurement.

Primary Outcome Measure

Absolute fluorescence unit (AFU) [ Time Frame: Intraoperative measurement ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins Bayview Medical CenterBaltimoreMaryland21224
Henry T Shu, MD
[email protected]
240-805-0284
The Johns Hopkins HospitalBaltimoreMaryland21201
Henry T Shu, MD
[email protected]
240-805-0284

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