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

NCT07004764 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB00502503
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Tibial Plateau Fracture; Ankle Fracture (Bimalleolar Equivalent, Bimalleolar, or Trimalleolar); Calcaneus Fractures; Talus Fracture; Wound Infection Deep; Wound Infection Post-Traumatic; Wound Dehiscence, Surgical; Pilon Fracture of Tibia; Achilles Tendon Repairs/Reconstructions

Keywords

Laser-assisted indocyanine green angiography; nitropaste; nitroglycerin; topical nitroglycerin; Achilles tendon repairs/reconstructions; Pilon Fracture of Tibia; Tibial Plateau Fracture; Ankle Fracture (bimalleolar equivalent, bimalleolar, or trimalleolar); Calcaneus Fractures; Talus fracture; Wound Dehiscence; Wound infection; tissue perfusion; Orthopaedic surgery

Outcome Measures

Primary Outcomes (4)

• Absolute fluorescence unit (AFU)

  raw fluorescence measurement

  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.

  Intraoperative measurement

• mean incision perfusion (MIP)

  the mean fluorescence of 10 points adjacent to the incision.

  Intraoperative measurement

• mean perfusion impairment (MPI)

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

  Intraoperative measurement

Secondary Outcomes (4)

• Number of Participants with Wound dehiscence

  From surgery to 3 months post-operation

• Number of participants with Wound necrosis

  From surgery to 3 months post-operation

• Number of participants with Superficial infection

  From surgery to 3 months post-operation

• Number of participants with Deep infection

  From surgery to 3 months post-operation

Other Outcomes (2)

• recruitment rate

  From study start to final recruitment approximately 8 months

• retention rate

  From study start to 3 months after final patient is recruited

Study Arms (1)

Nitropaste

EXPERIMENTAL

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%

Interventions

Nitroglycerin Ointment 2% DRUG

Patients will have pre- and post-nitropaste tissue perfusion measurement with the LA-ICG system.

Nitropaste

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Orthopaedic Trauma Association: collaborator

Study Sites (2)

The Johns Hopkins Hospital

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Sanniec K, Teotia S, Amirlak B. Management of Tissue Ischemia in Mastectomy Skin Flaps: Algorithm Integrating SPY Angiography and Topical Nitroglycerin. Plast Reconstr Surg Glob Open. 2016 Oct 6;4(10):e1075. doi: 10.1097/GOX.0000000000001075. eCollection 2016 Oct.

  PMID: 27826472 BACKGROUND

MeSH Terms

Conditions

Tibial Plateau Fractures; Ankle Fractures; Surgical Wound Dehiscence; Wound Infection

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Wounds and Injuries; Tibial Fractures; Knee Injuries; Leg Injuries; Ankle Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Study Officials

• Henry T Shu, MD

  Johns Hopkins University

  STUDY DIRECTOR

• Babar Shafi, MD, MSPT

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henry T Shu, MD

CONTACT

2408050284; hshu5@jhmi.edu

Babar Shafiq, MD, MSPT

CONTACT

4432877847; bshafiq2@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single-arm open-label prospective clinical trial with no randomization or placebo. All patients will serve as own controls for LA-ICG fluorescence measurement. This study is considered a Phase I feasibility study, or a Stage 2a Development study under the IDEAL Framework

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 4, 2025
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)