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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Nitroglycerin Ointment 2%

    Drug

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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: NitropasteExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Absolute fluorescence unit (AFU)

raw fluorescence measurement

Time frame
Intraoperative measurement
2

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
3

mean incision perfusion (MIP)

the mean fluorescence of 10 points adjacent to the incision.

Time frame
Intraoperative measurement
4

mean perfusion impairment (MPI)

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

Time frame
Intraoperative measurement

Secondary outcomes

1

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
2

Number of participants with Wound necrosis

participants with any death of peri-incisional skin

Time frame
From surgery to 3 months post-operation
3

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
4

Number of participants with Deep infection

Any wound infection that requires surgical management

Time frame
From surgery to 3 months post-operation

Other outcomes

1

recruitment rate

Patients recruited into the study per time and per patients approached

Time frame
From study start to final recruitment approximately 8 months
2

retention rate

Percent patient follow-up at 3 months postoperative

Time frame
From study start to 3 months after final patient is recruited

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Orthopaedic Trauma Association

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: