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Efficacy of Hyperbaric Oxygen Therapy in Laryngectomy Patients

NCT00026975 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2006-08-18

No results posted yet for this study

Summary

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

  • Laryngeal Cancer

Interventions

PROCEDURE

Hyperbaric Oxygen

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    lead NIH

Principal Investigators

  • Ara A. Chalian, MD · Clinical Faculty, Dept. ORLHNS, University of Pennsylvania

  • Stephen R. Thom, MD PhD · Chief of Section, Dept. of Hyperbaric Medicine, University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-09-30
Completion
2005-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00026975 on ClinicalTrials.gov