Oral Cavity Reconstruction for Oral Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand why infections sometimes occur after surgery to rebuild parts of the mouth affected by cancer. Researchers seek to observe how bacteria and antibiotics interact during these procedures to uncover potential causes of these infections. This study targets individuals who have had oral or throat cancer and plan to undergo surgery involving mouth reconstruction with tissue flaps. Participants must use a specific antibiotic, ampicillin/sulbactam, as part of their treatment plan. As an unphased trial, this study allows participants to contribute to important research that could improve surgical outcomes for future patients.
Do I need to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that oral cavity reconstruction is safe?
Research has shown that rebuilding the mouth after oral cancer surgery can sometimes lead to problems. One study found that the wound reopened in 10% of cases, and infections occurred in about 9% of cases. These findings suggest that while the procedure is generally safe, some risks exist.
Doctors have performed these surgeries for a long time, so they understand the risks and how to manage them. If concerns arise, discussing them with a doctor can help clarify how these numbers might relate to an individual case.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to uncover the reasons why surgical site infections occur after oral cancer surgeries. Unlike standard treatments that focus solely on infection management, this study seeks to understand the underlying mechanisms causing these infections. By identifying these mechanisms, the trial could lead to new preventative strategies, making surgeries safer and reducing recovery time for patients.
What evidence suggests that oral cavity reconstruction is effective for preventing surgical site infections?
Studies have shown that rebuilding the mouth area can lead to positive results for patients. One study found that 62.5% of patients experienced excellent improvements in function after 12 months, while another 15% showed good improvements. This demonstrates the effectiveness of these surgeries in restoring function. Additionally, research has found that the implants used after these surgeries have a long lifespan, with a success rate of up to 92.5%. These findings suggest that oral cavity reconstruction, which participants in this trial will undergo, effectively improves both function and quality of life for patients after oral cancer surgery.14678
Who Is on the Research Team?
Joseph Zenga, MD
Principal Investigator
Medical College of Wisconsin
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Sample Collection
Participants undergo standard of care oral cavity reconstruction surgery with biospecimen collection
Post-operative Monitoring
Participants are monitored for surgical site infections and antibiotic concentrations are measured
Follow-up
Participants are monitored for safety and effectiveness after surgery
What Are the Treatments Tested in This Trial?
Interventions
- Oral Cavity Reconstruction
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The cohort will be oral cancer patients undergoing standard of care oral cavity reconstruction.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator
Citations
Functional Outcomes and Quality of Life Following ...
At 12 months, 62.5% of our patients achieved excellent functional outcomes, and 15.0% achieved good outcomes, underscoring the efficacy of SCF ...
Retrospective analysis on prognosis of oral cancer patients ...
This study analyzed postoperative outcomes such as complications, recurrence rate, and survival rate by these two approaches.
Clinical and oncological outcome in locoregional ...
The 3-year overall survival was 31,4% with advanced tumor stage and reduced clinical performance score at the start of treatment being independently associated.
Efficacy of Oral Rehabilitation Techniques in Patients With ...
The survival rate was 92.5% for implants placed after ablative surgery and 89.5% for those placed after oncological treatment. The difference in ...
Oncologic outcomes following neoadjuvant ...
The addition of adjuvant chemotherapy to RT was associated with a 5% reduction in the risk of mortality (95% CI: 1%-14%), the protective effect ...
Incidence of flap-related complications in the oral ...
Subgroup analysis of complications indicated that the most common complications were wound dehiscence (10%), infections (9%), total/partial flap ...
Reconstruction in early squamous cell carcinoma of the ...
Estimated 5-year overall and progression-free survival was 85 % and 77 % respectively with no significant difference between stage I or II cancer patients.
Reconstruction in oral malignancy: Factors affecting morbidity ...
87.4% cases were newly diagnosed carcinoma oral cavity. Surgery was the most common upfront treatment modality with seven cases accounting for 6.3% cases.
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