Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging.
Starting soon · Phase 1 · Has a placebo group
Conditions studied: 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
In brief
Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Feasibility Study on Nitropaste Using Intraoperative SPY Imaging.
Key facts
- Study ID
- NCT07004764
- Run by
- Johns Hopkins University
- People needed
- 15
- Starts
- 2026-11-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-03-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults aged 18 years or older.
- Undergoing surgery for one of the following procedures:
- Current Procedural Terminology (CPT) 28415 - Open reduction calcaneal fracture ± internal/external fixation
- CPT-27814 - Open reduction of bimalleolar fracture ± internal/external fixation
- CPT-27822 - Open reduction trimalleolar ankle fracture, medial and lateral malleoli only, ± internal/external fix
- CPT-27823 - Open reduction trimalleolar ankle fracture, including posterior malleolus, ± internal/external fix
- CPT-27826 - Open reduction pilon fracture, internal/external fixation of fibula ONLY
- CPT-27827 - Open reduction pilon fracture, internal/external fixation of tibia ONLY
- CPT-27828 - Open reduction pilon fracture, internal/external fixation of tibia AND fibula
- CPT-27535 - Open reduction unicondylar tibial plateau fracture, ± internal/external fixation
- CPT-27536 - Open reduction bicondylar tibial plateau fracture, ± internal/external fixation
- CPT-28445 - Open reduction of talus fracture, ± internal/external fixation
- CPT-27650 - Primary Achilles tendon repair
- English-speaking
- Able to provide informed consent during preoperative clinic visit, in the preoperative nursing area, or on inpatient units.
You may not qualify if…
- Contraindications to nitroglycerin, including known allergy.
- Allergy to indocyanine green or components of ICG dye, including allergies to iodine or shell-fish.
- Severe kidney injury, as determined by attending surgeon and/or anesthesiologist, that would impair clearance of ICG dye.
- Pregnant patients
Where it is running
- The Johns Hopkins Hospital — Baltimore, Maryland, United States
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.