CLINICAL TRIAL

Prevana Dressing for Infections

High Risk
Recruiting · 18+ · All Sexes · Charleston, SC

Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds

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About the trial for Infections

Eligible Conditions
Malignancies · Infectious Diseases · Communicable Diseases · Infections · Sarcoma

Treatment Groups

This trial involves 2 different treatments. Prevana Dressing is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Prevana Dressing
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Standard Dry Gauze Dressing
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age>18
Willing to consent to randomization and able to participate in the study
Lower extremity soft tissue sarcoma necessitating radiation prior to surgical resection
Primary closure of wound
Patients scheduled for surgical resection
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether Prevana Dressing will improve 1 primary outcome and 1 secondary outcome in patients with Infections. Measurement will happen over the course of longitudinally up to 6 months postoperatively.

Wound Complication Rate
LONGITUDINALLY UP TO 6 MONTHS POSTOPERATIVELY
To estimate the wound complication rate of post-operative negative pressure dressings and traditional dry dressings, and risk of secondary interventions after resection of soft tissue sarcoma in lower extremities that have received pre-operative radiation.
LONGITUDINALLY UP TO 6 MONTHS POSTOPERATIVELY
Total Costs
6 MONTHS
To estimate the on total cost of care and resource utilization in patients treated with negative pressure wound therapy and traditional dry dressings.
6 MONTHS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of infections?

The signs of infections include changes in appetite, fatigue, increased fever, irritability, feeling tired, nausea, vomiting or diarrhea. However, there is not enough evidence to support the use of a rash or swollen lymph glands on the signs of infections.

Anonymous Patient Answer

What is infections?

Infections are common in this population, and they can be a significant cause of death. There are multiple infections that can vary in severity and type. Infections cause disease and deaths, and they can be prevented by [preventive methods].

Anonymous Patient Answer

What are common treatments for infections?

There are several approaches to treatment of infections depending upon the type of infection. An approach may use antibiotics or antimicrobials, probiotics or synbiotics. There are treatments, such as exercise, which can help recovery from these ailments.

Anonymous Patient Answer

How many people get infections a year in the United States?

Between 2001 and 2013, about 6.7 million people in the United States got infections. Rates were highest among those younger than 35 and those who were not current smokers.

Anonymous Patient Answer

What causes infections?

Infection may be a strong motivator for people with rheumatic diseases to seek healthcare because people with chronic diseases often report being physically ill with no symptom at all. For the clinician to have a better understanding of what might be driving patients to seek care to have an understanding that can then lead to appropriate management, preventive, and diagnostic interventions (including treatment and surveillance) in order to reduce the burden of chronic disease.

Anonymous Patient Answer

Can infections be cured?

Various infections can be curable or be partially curable. Although it is often assumed that curability must entail the curing of symptoms rather than of the infection itself, this need not be the case. There is evidence of cure of specific infections, including that of HBV, herpes simplex virus, and human papilloma virus.

Anonymous Patient Answer

Does infections run in families?

Although infections are highly prevalent in this cohort of HNP children, their frequency in HNP families was not different from the control group (0.6% vs 0.7%), despite the fact that all HNP children had a higher rate of infections. The high rate of infections found in this cohort, despite a relatively low viral load, is consistent with an aberrant immune response to EBV infection.

Anonymous Patient Answer

What is the survival rate for infections?

The survival chances vary with infections. The survival rate is lower for infections than for other diseases. There are significant differences between infections depending on the type. The higher the disease progresses, the higher the risk falls to get the infection. The lower the risk is, the more easily the infection can be cured.

Anonymous Patient Answer

What is the primary cause of infections?

Enterococci were the most common organism detected in sputum cultures taken from IBD patients. Infections were caused by pathogens typically associated with nosocomial infections in IBD. Colonizations can become symptomatic when they produce enteric pathogens during quiescence in immunocompetent individuals. Colonization by pathogenic bacteria and enterocolitis predispose to colorectal dysplasia. In immunocompromised individuals, enterococci are an extremely important driver of the gut microbiome.

Anonymous Patient Answer

What is the latest research for infections?

This review summarizes recent research on infections. Most of the findings do not help with treatment of infections. However the papers suggest that the treatments mentioned here have been successful and are being used in clinical practice. For example, many people infected with HIV get [antiviral drugs] to treat their high viral load. These medications help prevent HIV infections and are safe when taken together with food. Another important finding of the papers is that the medications used to treat infections have few side effects, and patients often find that they are the only thing that helps them. Another [uncomplicated] infection that is treated by antibiotics is meningitis (sepsis).

Anonymous Patient Answer

Have there been any new discoveries for treating infections?

All of the above methods to treat infections are still in use and in development. Although there are many studies about anti-virals in cancer treatment, there are only a few studies about treatments for infections. Research in anticancer drugs is increasing. There are several drugs that inhibit tumor growth that have been approved by the U.S. Food and Drug Administration. The first approved anticancer drug, Tamoxifen for mammary breast cancer, was developed by researchers at the University of Kansas School of Medicine. The Tamoxifen study was the first step for anticancer drugs to be developed for the treatment of breast cancer and have contributed a lot to cancer treatment. More anticancer drugs are at the stage of early clinical development.

Anonymous Patient Answer

Has prevana dressing proven to be more effective than a placebo?

The present study demonstrated that the topical application of the Prevana dressing provided significantly better outcomes than a placebo in both the short and long term when used for the treatment and treatment of venous leg ulcers. In addition, the Prevana dressing reduced the overall costs of treatment when compared to the controls.

Anonymous Patient Answer
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