Nitroglycerin Ointment for Wound Healing
(SPY NITROPASTE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests nitroglycerin ointment to determine if it can improve wound healing after certain lower leg surgeries. The goal is to assess whether this ointment boosts blood flow to the affected area, aiding in better and faster wound healing. Suitable participants include those undergoing specific surgical procedures, such as ankle or Achilles tendon repairs, who can speak English and provide informed consent. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially beneficial treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that nitroglycerin ointment is likely to be safe for humans?
Research has shown that nitroglycerin ointment is generally safe for aiding wound healing. In a study involving patients with serious bone injuries, no systemic side effects occurred. Most patients, about 83.3%, healed without issues, while 16.7% experienced problems such as wound reopening or infection. These findings suggest that although some local side effects might occur, the treatment is mostly well-tolerated.12345
Why do researchers think this study treatment might be promising?
Most treatments for wound healing focus on cleaning, dressing, and sometimes antibiotics to prevent infection. However, nitroglycerin ointment is unique because it enhances blood flow directly to the wound area, which can speed up healing. Researchers are excited about nitroglycerin's ability to improve tissue perfusion, which is crucial for delivering nutrients and oxygen to the wound. This approach could potentially lead to faster recovery times compared to traditional methods.
What evidence suggests that nitroglycerin ointment might be an effective treatment for wound healing?
Research has shown that nitroglycerin ointment can aid in wound healing. In one study, 83.3% of patients with serious bone injuries healed well after using the ointment, while only 16.7% experienced issues such as wound reopening. Another study found that nitroglycerin reduced tissue damage in surgery patients. These studies reported no major side effects, suggesting it as a promising option for improved healing. In this trial, all participants will receive nitroglycerin ointment, known as Nitropaste, to evaluate its effectiveness in wound healing.23678
Who Is on the Research Team?
Henry T Shu, MD
Principal Investigator
Johns Hopkins University
Babar Shafi, MD, MSPT
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for individuals undergoing lower extremity orthopedic surgery who are at high risk of poor wound healing, such as those with fractures or soft tissue injuries in the ankle, knee, or heel. Specific conditions include broken ankles and knees, wound infections, abscesses, incisional hernias, Achilles tendon repairs/reconstructions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of nitropaste intraoperatively with perfusion measurements using LA-ICG
Follow-up
Participants are monitored for wound complications and safety outcomes
Recruitment and Retention
Recruitment and retention rates are assessed to evaluate trial feasibility
What Are the Treatments Tested in This Trial?
Interventions
- Nitroglycerin Ointment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Orthopaedic Trauma Association
Collaborator