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NCT04967391 · ClinicalTrials.gov registry record · Phase 3
Tumescence in HNC Skin Graft Reconstruction
A Phase 3 study of Head and Neck Cancer and Surgery--Complications, sponsored by University of California, Davis.
- Active
- Registry status
- Phase 3
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT04967391: Active Phase 3 study of Head and Neck Cancer and Surgery--Complications, sponsored by University of California, Davis.
NCT04967391 is a Phase 3 study of Head and Neck Cancer and Surgery--Complications that is active but no longer recruiting, run by University of California, Davis. The registered enrollment target is 58 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04967391, a Phase 3 study of Head and Neck Cancer and Surgery--Complications, is active but no longer recruiting, sponsored by University of California, Davis.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
Our primary objective is to determine if the use of tumescence has a meaningful effect on STSG uptake at the recipient site. This is an important outcome because poor graft uptake results in the need for prolonged local wound care, additional clinic visits for patients and increased risk of infection. A prospective, randomized comparison of the tumescence to our current standard of care will allow us to definitively evaluate any benefits to this technique. Tumescence is commonly used in the treatment of burn patients to minimize blood loss during both tangential excision of eschar and during harvest of split-thickness grafts for reconstruction. This is considered the standard of care in burn surgery as using tumescence has been clearly demonstrated to reduce intraoperative blood loss during harvest of large skin grafts and excision of large burns when compared with the application of topical epinephrine as was the historic standard practice.4-6 Tumescence also creates a firm and uniform surface from which to harvest the skin graft, which the investigators believe may improve the quality of harvest and rate of skin graft take.
Primary Outcome
To assess the use of tumescence during STSG harvest affect graft take at the recipient site as measured by percentage of graft uptake as measured using ImageJ (open source software available from NIH) at one month post-operatively
Conditions Studied
Interventions
- PROCEDURE Tumescence During STSG Harvest
Study Locations (1)
California
- UC Davis Health - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2026-08-30 |
| Phase | Phase 3 |
What the registry record for NCT04967391 still lists
NCT04967391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (78% lower).
The record links to 3 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which Tumescence During STSG Harvest is the first listed.
NCT04967391 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04967391 about?
NCT04967391 is a clinical study titled "Tumescence in HNC Skin Graft Reconstruction". Our primary objective is to determine if the use of tumescence has a meaningful effect on STSG uptake at the recipient site. This is an important outcome because poor graft uptake results in the need for prolonged local wound care, additional clinic visits for patients and increased risk of infectio...
What is the current status of trial NCT04967391?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 58 participants. The study started on 2021-09-01. Estimated completion is 2026-08-30.
What conditions does trial NCT04967391 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Surgery--Complications, Graft Failure.
What interventions are being tested in trial NCT04967391?
The interventions under investigation include: Tumescence During STSG Harvest (PROCEDURE).
Who is sponsoring clinical trial NCT04967391?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04967391 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04967391's enrollment target sits among peer trials
58 122nd of 250 higher than 129 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer 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.
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