Clinical trial · Interventional
Efficacy of Hyperbaric Oxygen Therapy in Laryngectomy Patients
Clinical Outcomes Modeling for Laryngectomy Surgery Patients and Efficacy of Hyperbaric Oxygen Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to develop a predictive model for the development of wound complications in patients undergoing laryngectomy surgery for laryngeal/adjoining structure cancers, and to evaluate the clinical efficacy of hyperbaric oxygen for the prevention/management of wound complications in this previously irradiated population. The eligibility profile welcomes the involvement of patients in need of laryngectomies for newly diagnosed cancers and for failed chemoradiation. Patients are afforded the opportunity to be cared for by some of the most distinguished head \& neck surgeons and hyperbaric medicine physicians at the University of Pennsylvania in Philadelphia, the oldest teaching medical facility in the country, as well as the Philadelphia Veterans Affairs Medical Center. In addition, participants will be contributing to a body of research uncovering new methods for the assessment of tissue/tumor oxygenation, modeling to promote early wound complication identification, and confirming the role of hyperbaric oxygen therapy in the care and prevention of these problem wounds.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laryngeal Cancer | Malignant Laryngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperbaric Oxygen | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for Prospective Trial: * a lesion either suspicious for or diagnosed by biopsy as laryngeal/adjacent pharyngeal cancer requiring a total or partial laryngectomy, or if previously irradiated and ineligible for the randomized trial. * no history of radiation to the head/neck * adequate liver and kidney function * no plans to become pregnant or conceive for the duration of the study Inclusion Criteria for Randomized Trial: * have been previously irradiated for a head/neck cancer requiring a total laryngectomy * demonstrate a lesion either suspicious for or diagnosed by biopsy as laryngeal/adjacent pharyngeal cancer * have adequate liver and kidney function * meet physical requirements for hyperbaric oxygen therapy * agree to randomization of care to receive a laryngectomy and standard follow-up care vs. hyperbaric oxygen therapy preoperatively and postoperatively
References
Publications (0)
Data not yet available