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Nitropaste for Enhanced Wound Healing in Lower Leg Surgery

This study is looking at how a medication called Nitroglycerin Ointment 2% (nitropaste) might improve wound healing after certain lower leg surgeries. These surgeries include repairs of the Achilles tendon, ankle fractures, and fractures of the shin bone (tibia) or heel bone (calcaneus). The goal is to see if nitropaste can increase blood flow to the surgical area, which is important for healing and preventing problems like infections. Researchers will measure blood flow using a special imaging system called LA-ICG before and after applying nitropaste during surgery. This study is for adults aged 18 and older who are having one of these specific lower leg surgeries. The study aims to see if nitropaste can improve immediate tissue blood flow.

Study design
This is an interventional study with a planned enrollment of 15 participants. It is not specified if it is randomized or blinded.
What's involved
Patients will have tissue perfusion measured with the LA-ICG system before and after nitropaste application during their surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints (blood flow measurements) are taken during the surgery itself.

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NCT07004764

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

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Johns Hopkins University
~15 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:Nitroglycerin Ointment 2%

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Absolute fluorescence unit (AFU)
Measured over Intraoperative measurement
+3 more outcomes measured

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

Explore related trials

Ankle FractureFracture of calcaneusFracture of talusFracture of tibial plateauPilon fractureRepair of tendo achilles

Where it's being run

2 sites across 1 states
Maryland2

Study leadership

  • Henry T Shu, MD · STUDY_DIRECTOR · Johns Hopkins University
  • Babar Shafi, MD, MSPT · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Henry T Shu, MD
[email protected]
2408050284
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Absolute fluorescence unit (AFU)Intraoperative measurement

    raw fluorescence measurement

  • Relative fluorescence unit (RFU)Intraoperative measurement

    Will be calculated as a ratio of the mean fluorescence measure to the mean "normal" measurement. The mean "normal" measurement will be defined as the maximal signal intensity in a region outside of the wound area.

  • mean incision perfusion (MIP)Intraoperative measurement

    the mean fluorescence of 10 points adjacent to the incision.

  • mean perfusion impairment (MPI)Intraoperative measurement

    the difference between mean of each pair of points on each side of the incision.