Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging.
Launched by JOHNS HOPKINS UNIVERSITY · May 27, 2025
Trial Information
Current as of July 01, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a treatment called Nitropaste to see if it can improve blood flow to wounds during certain orthopedic surgeries, specifically for conditions like Achilles tendon repairs and various types of fractures in the leg and ankle. The goal is to find out if using Nitropaste, along with a special imaging technique called SPY Imaging, can help reduce the risk of complications like infections or delayed healing after surgery. This research is still in the early stages and is not yet recruiting participants.
To be eligible for this trial, participants need to be adults aged 18 or older who are scheduled for specific surgeries related to fractures or tendon repairs. They should also be able to speak English and provide their consent to participate. However, individuals who have allergies to nitroglycerin or certain dyes used in the imaging process, those with severe kidney problems, or pregnant women cannot participate. If you join the study, you can expect to receive the usual care for your surgery, along with the added treatment and monitoring related to the trial.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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
About Johns Hopkins University
Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Patients applied
Trial Officials
Henry T Shu, MD
Study Director
Johns Hopkins University
Babar Shafi, MD, MSPT
Principal Investigator
Johns Hopkins University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported