A Phase 1 interventional study of Nitroglycerin Ointment 2% in Achilles Tendon Repairs/Reconstructions, Pilon Fracture of Tibia and Tibial Plateau Fracture, sponsored by Johns Hopkins University. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Johns Hopkins University · Phase 1, Interventional, and Treatment
Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Feasibility Study on Nitropaste Using Intraoperative SPY Imaging.
Tissue perfusion is a critical determinant of wound healing, particularly in lower extremity surgery where wound necrosis, dehiscence, and infection can result in limb loss. Despite current advances in wound therapy, rates of wound complications for certain lower extremity incisions remain high. Thus, there remains a critical need to identify agents that may potentially augment wound healing in orthopaedic surgery.
Nitropaste has been successfully used in plastic surgery to enhance perfusion and reduce flap necrosis, but its role in orthopaedic surgery is under-explored. In a meta-analysis of 6947 patients from 3 randomized controlled trials (RCTs) and 2 retrospective studies found that the use of nitropaste was associated with 0.23 odds [0.10-0.53, 95% confidence interval] of reduced mastectomy flap failure. Preliminary data from the investigator's institution involving 18 patients who received intraoperative nitropaste showed no adverse hypotensive effects, though wound complications occurred in three cases. Laser Assisted Indocyanine Green (LA-ICG) provides real-time, quantitative perfusion measurements, making it an ideal tool to evaluate the efficacy of nitropaste. Therefore, The purpose of this study is to evaluate the effects of nitropaste on immediate tissue perfusion and wound complications in high-risk lower extremity orthopaedic incisions using LA-ICG. Additionally, the investigators will assess the safety of single-dose nitropaste in these patients. The investigators hypothesize that intraoperative nitropaste application will significantly improve tissue perfusion, which in turn would be associated with reduced wound complications, with minimal adverse effects.
Aim 1: To evaluate the effect of nitropaste on immediate tissue perfusion in lower extremity orthopaedic incisions using LA-ICG.
Aim 2: To assess trial feasibility and ability to identify wound complications for a future large-scale trial.
Aim 3: To assess the safety of nitropaste in lower extremity orthopaedic surgeries.
32 studies on the registry are indexed under Tibial Plateau Fractures; 12 are open to participants now.
This study's planned enrollment of 15 is below the median of 56 across 21 interventional studies indexed under Tibial Plateau Fractures.
Browse Tibial Plateau Fractures studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Undergoing surgery for one of the following procedures:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Nitroglycerin Ointment 2%
Patients will have pre- and post-nitropaste tissue perfusion measurement with the LA-ICG system.
Absolute fluorescence unit (AFU)
raw fluorescence measurement
Time frame: Intraoperative measurement
Relative fluorescence unit (RFU)
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.
Time frame: Intraoperative measurement
mean incision perfusion (MIP)
the mean fluorescence of 10 points adjacent to the incision.
Time frame: Intraoperative measurement
mean perfusion impairment (MPI)
the difference between mean of each pair of points on each side of the incision.
Time frame: Intraoperative measurement
Number of Participants with Wound dehiscence
participants with wound dehiscence (when two edges of a wound separate)
Time frame: From surgery to 3 months post-operation
Number of participants with Wound necrosis
participants with any death of peri-incisional skin
Time frame: From surgery to 3 months post-operation
Number of participants with Superficial infection
participants with any wound infection that is treated only with oral antibiotics
Time frame: From surgery to 3 months post-operation
Number of participants with Deep infection
Any wound infection that requires surgical management
Time frame: From surgery to 3 months post-operation
recruitment rate
Patients recruited into the study per time and per patients approached
Time frame: From study start to final recruitment approximately 8 months
retention rate
Percent patient follow-up at 3 months postoperative
Time frame: From study start to 3 months after final patient is recruited
Plan to share: No — No sharing will occur to protect patient Protected Health Information (PHI)
Start is estimated for Nov 2026; primary completion for Sep 2027, 10 months later.
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Studies of the drug tested here: Nitroglycerin