Health Trials

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

ConditionsAchilles Tendon Repairs/ReconstructionsPilon Fracture of TibiaTibial Plateau FractureAnkle Fracture (Bimalleolar Equivalent, Bimalleolar, or Trimalleolar)Calcaneus FracturesTalus FractureWound Infection DeepWound Infection Post-TraumaticWound Dehiscence, Surgical
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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

Eligibility criteria

Qualifiers

Adults aged 18 years or older.

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Nitroglycerin Ointment 2%

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators

Johns Hopkins University

Lead sponsor

Orthopaedic Trauma Association

Collaborator

Source ClinicalTrials.gov