The Reframe for Wounds

1
Effectiveness
1
Safety
Rhode Island Hospital, Providence, RI
Wounds+1 More
The Reframe - Behavioral
Eligibility
Any Age
All Sexes
Eligible conditions
Wounds

Study Summary

Reframing Firearm Injury Prevention Through Bystander Interventions for Youth

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Eligible Conditions

  • Wounds
  • Wounds and Injuries
  • Firearm Injury

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether The Reframe will improve 6 primary outcomes, 4 secondary outcomes, and 1 other outcome in patients with Wounds. Measurement will happen over the course of 0, 3, and 6 months.

Month 6
Change in Attitudes via Adapted Theory of Planned Behavior Scale
Change in Intention to Use Behavioral Intervention Skills via Cook-Craig et al 2014
Change in Knowledge of Firearm Injuries in the US
Change in Knowledge via Adapted Theory of Planned Behavior Scale
Change in Perceived Behavioral Control via Adapted Theory of Planned Behavior Scale
Change in Subjective Norms via Adapted Theory of Planned Behavior Scale
Month 6
Change in Use of Behavioral Intervention Skills via Cook-Craig et al 2014
3 and 6 months
Acceptability of Intervention via The Ottawa Acceptability Scale
Barriers to Intervention via Qualitative Interviews Using the Consolidated Framework for Intervention Research
Facilitators of Intervention via Qualitative Interviews Using the Consolidated Framework for Intervention Research
Feasibility of Intervention via Percent of Intervention Activities Completed

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Intervention Group

This trial requires 5500 total participants across 2 different treatment groups

This trial involves 2 different treatments. The Reframe 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.

Intervention Group
Behavioral
25 Randomized 4-H Shooting Sport Clubs that will receive The Reframe intervention.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 and 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 and 6 months for reporting.

Who is running the study

Principal Investigator
M. L. R.
Megan L. Ranney, MD
Rhode Island Hospital

Closest Location

Rhode Island Hospital - Providence, RI

Eligibility Criteria

This trial is for patients born any sex of any age. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Membership of child participant in local 4-H Shooting Sports Club OR Parent of a child participant in local 4-H Shooting Sports Club OR Community member of a participating local 4-H Shooting Sports Club

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 is wounds?

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Most non-fatal traumatic wounds heal without complications, and many have a fast rate of healing. It is, however, common for wounds to remain open, or heal with a non-healing scar. This can be especially troublesome for people with chronic wounds or wounds that require a major operation such as amputation. Non-healing scarring also has serious, long term implications for the person and the health system.

Unverified Answer

What are the signs of wounds?

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Wounds with oozing pus or discharge may indicate a wound infection or a skin infection, while a black spot on the wound would indicate necrosis of the wound. The wound may become swollen and hard when it has been contaminated with bacteria, particularly skin flora, giving rise to pus in the wound. Other signs of infection included fever, swelling of the lymph nodes in the vicinity of the wound and a reduced range of motion of the joints. There is also the possibility that a patient will also experience pain when being treated for an infection or a disease.

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

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There will be many more people hospitalized with a wound each year in the United States than previously thought. This is especially true for patients with diabetic foot ulcers, who comprise 16% of hospital admissions. Most patients have at least one underlying disease and almost half have a history of recent amputation. Wounds are a common occurrence after major surgery, particularly orthopedic surgery. Most wounds are not infected. Many of the wounds would be manageable without a skin graft.

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Can wounds be cured?

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In a recent study, findings does not support a strong case for the view that wounds can be cured. However, we cannot rule out a potential cure from wound healing itself. It is important to consider the possibility that this might be achieved by exploiting wound healing.

Unverified Answer

What are common treatments for wounds?

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Wounds are widely treated using a variety of conservative, semi conservative, and operative treatments. Surgical techniques are used frequently, especially in severely impaired patients with prolonged immobilization.

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What causes wounds?

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Many wounds are a result of accidents that have gone unnoticed, although the underlying mechanism is not yet clear. However, the majority of injuries can be prevented by prevention and treatment.

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Have there been other clinical trials involving the reframe?

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There has been considerable debate surrounding the effectiveness and usefulness of reframe therapy. Since reframe therapy takes place at a physician practice, it is difficult to conduct rigorous trials; however, the most compelling evidence in support of it comes from trials involving different patient populations (post-polio patients and the elderly) and that are being conducted outside of the doctor-patient setting. In the more recent ones, the therapies have not been evaluated, which prevents direct comparison between the studies. Nonetheless, there is a strong consensus that, at this time, reframe therapy is an alternative to existing approaches in post-polio syndrome. The studies suggest that the treatment leads to improved lung functions and a less active course of the illness.

Unverified Answer

What is the primary cause of wounds?

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The wound that is seen is of particular concern because it may be the first presentation of cancer, especially in patients who did not remember their medical history. Many cases of wounds are related to chronic infections that are either not recognized or treated. Surgical wounds and the skin are an important area for the detection of early neoplasm. Physicians, therefore, should remain alert for the first identification of a wound.

Unverified Answer

What is the latest research for wounds?

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Wounds require a constant amount of effort to clean and control to heal and prevent the formation of a wound callus or scar. Clinicians should pay attention to their patient's wounds to [clean, control, and prevent the formation of a callus by controlling the wounds.] The most effective way to [clean, control and prevent a callus from forming is the proper application of wound dressings. Wound dressings are [most] importantly, [absorbable] and [mesh] gauze. But we have found that these are not the most [effective.

Unverified Answer

What are the latest developments in the reframe for therapeutic use?

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At this time, there is no reliable data on [the clinical use of reframe (Reframe Dose, Reframe, RYO Dose, Reframe Hx) for therapeutic use with a reframe that has been evaluated in clinical trials (Reframe Hx Dose, RYO Dose, Reframe Dose) by the Food and Drug Administration to date (Reframe: FDA, October 3, 2014)] to support its regulatory decision. Clinical studies conducted in the last 2 years (Reframe: EudraCT 2017/0312-55) and reported (Reframe Dose, RYO Dose, and Reframe Hx Dose, Reframe Dose) and are ongoing.

Unverified Answer

Does wounds run in families?

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We were unable to demonstrate a significant correlation between wounds in relatives and wounds in probands, with the exception of wounds caused by venereal diseases. We suggested that research on the familial transmission of venereal diseases be a priority within the field of the family planning. Additional research studies are needed, as there are many factors that need to be investigated in deeper detail such as the possibility of the transmission of an infection of a congenital origin.

Unverified Answer

What does the reframe usually treat?

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Reframing needs of patients with chronic wound in this study, could be accomplished mainly through the integration of the patient’s needs into the healing process; ensuring adequate supplies are available and that they are used appropriately; facilitating effective integration between the patient and clinician, and promoting the patient’s confidence, especially after the initial phase of treatment. A model of integration within the healing process could contribute to high-quality quality of management.

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