Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04967391 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Tumescence in HNC Skin Graft Reconstruction

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 18, 2026 (before its estimated August 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary and study completion dates: Aug 30, 2025 to Aug 30, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  2. Notable Primary and study completion dates: Dec 31, 2024 to Aug 30, 2025v7
  3. Minor Re-verified, no change to tracked fieldsv6
  4. Notable Primary and study completion dates: Dec 31, 2023 to Dec 31, 2024v5
  5. Minor Primary completion date: Aug 1, 2023 to Dec 31, 2023v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2021 to Sep 1, 2021
    • Site details revised
    v3
  2. Notable Start date: Aug 1, 2021 to Nov 1, 2021v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04967391
Lead Sponsor University of California, Davis
Conditions
(from sponsor)
Head and Neck Cancer, Surgery--Complications, Graft Failure
Related terms Head and Neck Neoplasms
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov