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ACTIVE NOT RECRUITING Phase 3

Tumescence in HNC Skin Graft Reconstruction

NCT04967391 · View on ClinicalTrials.gov ↗

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.

Interventions

  • PROCEDURE Tumescence During STSG Harvest

Study Locations (1)

California

  • UC Davis Health — Sacramento

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2021-09-01
Est. Completion 2026-08-30
Phase Phase 3

Sponsor

University of California, Davis

653 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04967391

The ClinicalTrials.gov registry entry for NCT04967391 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 653 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04967391 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04967391?

The interventions under investigation include: Tumescence During STSG Harvest (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04967391?

This trial is sponsored by University of California, Davis, which has 653 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial