Treatment for Wounds

Phase-Based Estimates
1
Effectiveness
1
Safety
Duke University, Durham, NC
Wounds+4 More
Eligibility
18+
All Sexes
Eligible conditions
Wounds

Study Summary

This study is evaluating whether the use of a new device may help reduce the need for additional surgery for wounds.

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Eligible Conditions

  • Wounds
  • Wounds and Injuries
  • Upper Extremity Wound
  • Lower Extremity Wound
  • Soft Tissue Abscesses
  • Traumatic Wounds

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome in patients with Wounds. Measurement will happen over the course of Enrollment - 3 months post-surgery.

Month 3
Change in bio-burden as measured by quantitative microbial PCR

Trial Safety

Trial Design

2 Treatment Groups

Wound vac application including irrigation

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Wound vac application including irrigation
Device
Wound vac application WITH irrigation for upper/lower extremity open wound
Wound vac application
Device
Wound vac application for open upper/lower extremity open wound

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: enrollment - 3 months post-surgery
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly enrollment - 3 months post-surgery for reporting.

Closest Location

Duke University - Durham, NC

Eligibility Criteria

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

Mark “yes” if the following statements are true for you:
18+yo with an injury or infection of the upper or lower extremity for which surgical debridement (in the operating room) followed by VAC application is planned.

Patient Q&A Section

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

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

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Most wounds are small, but 5% to 6% of those hospitalized are of major importance for surgeons and patients and account for approximately 5% of inpatient bed-days.

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What is wounds?

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Wounds are characterized by the disruption of normal functions, often due to trauma, surgery, and infection. Wounds can occur on limbs, head, face, abdomen, chest, and genitalia. Wounds are seen in up to 50% of patients undergoing surgery and in more than 90% of persons with burns.\n

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Can wounds be cured?

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Wounds can be completely and satisfactorily excised, but they will most likely return. There is significant value in the use of appropriate wound dressings. The treatment of a specific wound will depend on its cause and the circumstances, but may include excising and banding of the wound, or removing the entire wound with debridement of underlying soft tissue.

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What are common treatments for wounds?

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Treatment of wounds will always be based on the type and depth of the wound. For small wounds that are not open and do not have underlying infection, a bandage may be all that is needed. A wider variety of other dressings may be needed for larger wounds and deeper wounds with infection. In these cases it is necessary to use dressings that can be used to control infection and manage wound infection without causing a wound to become infected.

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What are the signs of wounds?

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Signs of wounds include the appearance of skin lesions. These may include bumps, rashes, blisters, abscesses and sores. Foul smells can often be detected. These signs and symptoms last less than 24 hours and are not very accurate signs of wounds. Subjective symptoms are more useful to assess the degree and severity of wounds, whereas the objective signs may be helpful to help diagnose and predict healing of wounds.

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What causes wounds?

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Wounds occur at a rate of one person per 5,000 and it is not clear why they happen or why they are usually not treated surgically. There is more than one reason they may not be surgically treated, but one very important reason is they are often not cared for adequately. It is possible that one way to prevent them from happening is to take better care of yourself (i.e. not smoke, get exercise and get some sun) and also not neglect wounds as many patients do but rather take notice of the person’s wounds and take their advice. Moreover, an effective way to deal with these wounds at home may be using bandaging materials in a health centre, getting some more sun and smoking less.

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Have there been any new discoveries for treating wounds?

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No new or unexpected treatments have been reported. More research is needed to develop a more effective treatment for chronic and acute wounds. Recent studies have demonstrated the potential of various cytokines as a way to accelerate wound healing by modulating the inflammatory response.

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Has treatment proven to be more effective than a placebo?

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Findings from a recent study suggest that patients treated with a single application of 0.1% povidone-iodine have less post-surgical infection than either those treated with anesthetic solution or patient's bed linen. Also, patients who were treated with the patient bed linen did not have infection or surgical site swelling.

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How serious can wounds be?

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Although they are relatively harmless to some extent, wounds have the potential to result in significant complications and death from infection. Therefore, wounds need to be taken seriously as medical emergencies.

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What does treatment usually treat?

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[There are many different methods of treatment for wounds and procedures used in modern medicine, but many are ineffective and often cause harm] (https://www.ncbi.nlm.nih.gov/public/science/current/pages/overview.cgi?pg=g_wound). However, in the past medical doctors thought that wounds were simply an imperfection in the patient’s body and would heal as the body did, while they actually saw patients as an individual, rather than a blank, lifeless object.\n\nThe patient is placed in a sterile environment. They may be given some simple painkillers during the procedure, if necessary.

Unverified Answer

What is treatment?

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There is no treatment that prevents necrosis of wounds. Any attempt to prevent necrosis of burn wounds is impractical, because many burns occur by accident. We need to be cautious from which burn wounds necrosis can develop. One of the most common causes of wound necrosis is infection. If infection is under control, wound necrosis does not develop, because the wound can heal without pain or risk of infection. However, if there is infection, wound necrosis develops, and it cannot be prevented. There is no cure for necrotic wounds. As a result, the only option is to remove necrotic tissue. It takes less time to remove necrotic tissue than to repair it.

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Have there been other clinical trials involving treatment?

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Almost all clinical trials are reported in the scholarly literature and, therefore, are widely available to the medical community. There have been several clinical trials on tinnitus treatments. The information presented here may help identify more effective treatment options.

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