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NCT03705637 · ClinicalTrials.gov registry record · Early Phase 1
Liposomal Bupivicaine for Skin Graft Donor Sites in Burn Patients
A Early Phase 1 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
NCT03705637: Clinical Trial Early Phase 1 study, sponsored by Massachusetts General Hospital.
NCT03705637 is a Early Phase 1 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 6 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03705637, a Early Phase 1 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Burn injuries are painful to patients and the sources of pain result from many areas including: the injury itself, wound care, and surgery. Inpatients that require surgical skin grafting is often required and the donor site of a skin graft is quite painful for patients. The investigators try to minimize that pain with local anesthetic as well as a combination of pain medications, the donor site pain lasts for days and is what patients often report as being the most painful part of their burn care. There has been the development of a new form of local anesthesia that can last up to 72 hours when injected into tissue. Based on encouraging results in the literature in areas outside of burns, this study aims to evaluate whether administration of this medication at the time of surgery can help improve pain for burn patients in the postoperative period.
Primary Outcome
Hypothesis: Subjects that receive Exparel will require fewer opioids to control their pain post-operatively (compared to historical controls).
Interventions
- DRUG Exparel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2020-03-24 |
| Phase | Early Phase 1 |
Why NCT03705637 stopped before completion
NCT03705637 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Exparel is the first listed.
NCT03705637 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03705637 about?
NCT03705637 is a clinical study titled "Liposomal Bupivicaine for Skin Graft Donor Sites in Burn Patients". Burn injuries are painful to patients and the sources of pain result from many areas including: the injury itself, wound care, and surgery. Inpatients that require surgical skin grafting is often required and the donor site of a skin graft is quite painful for patients. The investigators try to mini...
What is the current status of trial NCT03705637?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2019-06-01. Estimated completion is 2020-03-24.
What interventions are being tested in trial NCT03705637?
The interventions under investigation include: Exparel (DRUG).
Who is sponsoring clinical trial NCT03705637?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03705637's enrollment target sits among peer trials
6 1845th of 2000 higher than 114 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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