Treatment for Spine Surgeries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Michigan, Ann Arbor, MI
Spine Surgeries+2 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Prophylactic Application of an Incisional Wound Vac to Prevent Wound Complications in Obese Spine Surgery Patients

See full description

Eligible Conditions

  • Spine Surgeries
  • Wounds Vac

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome in patients with Spine Surgeries. Measurement will happen over the course of 6 weeks post surgery.

6 weeks post surgery
Post operative infection requiring return to operating room

Trial Safety

Trial Design

2 Treatment Groups

Standard Dressing
1 of 2
Wound Vac
1 of 2
Active Control

This trial requires 150 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.

Standard Dressing
Other
Standard Dressing
Wound Vac
Device
Wound vac

Trial Logistics

Trial Timeline

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

Who is running the study

Principal Investigator
R. P.
Prof. Rakesh Patel, Clinical Assistant Professor, Orthopaedic Surgery
University of Michigan

Closest Location

University of Michigan - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
I am scheduled to have surgery on my posterior spine. show original
You have a BMI over 35. show original

Patient Q&A Section

Can wounds be cured?

"The treatment of chronic wounds in a specialized center can result in significant improvement in healing time, without decreasing the quality of the healing process. The key parameters to consider are: type of wound and severity of underlying disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for wounds?

"The treatments discussed below can help treat most wounds. There are treatments that can help some wounds, but most treatments are recommended for wounds that do not heal for at least 10 days." - Anonymous Online Contributor

Unverified Answer

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

"Each year, 20,000 to 30,000 people enter emergency departments with a traumatic wound or laceration. The injuries can result in approximately 40,000 hospitalizations. Hospitals are responsible for approximately 80% of emergency room expenditures for treating wounds. Understanding which patients who receive these injuries have the highest mortality rates will help hospitals to reduce costs and to improve patient outcomes." - Anonymous Online Contributor

Unverified Answer

What are the signs of wounds?

"Most wounds of the paediatric patient have at least some of the features from this list. Some wounds, such as non-healing wounds, are often misdiagnosed. This article provides the doctor with some useful clues to how to deal with the child's wound, some of which may be useful even before clinical examination." - Anonymous Online Contributor

Unverified Answer

What is wounds?

"Wounds are wounds, which are defined as an injury. The most common kinds of wounds are abrasions, burns" "Eremiaphila albonotata\n\nEremiaphila albonotata is a species of praying mantis in the family Eremiaphilidae." - Anonymous Online Contributor

Unverified Answer

What causes wounds?

"Wounds are usually caused by a breach of the skin's surface and is therefore a wound. The most commonly involved injuries include abrasions, bruises, and lacerations and include the following pathological circumstances that occur in the epidermis: infections, chemicals, burns, trauma and pathologies.\n" - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating wounds?

"There has been a resurgence of interest in recent years due to an increase in the number of wound care patients and clinicians looking for safer and effective therapies to treat wounds. One of the largest challenges is coming up with an appropriate regimen that provides complete wound care for each patient including an effective antimicrobial regimen. The goal of treatment should be to help the immune system fight the infection without initiating a chronic wound state. There are many options such as: topical antimicrobials, conventional wound dressings, otozolid, miconazole, fusidic acid and sulfa compounds, and combinations of antibiotics with bioresorbable dressings." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of treatment?

"[About half of patients treated in NHS trusts in Scotland in 2009 reported experiencing at least one side effect from their antipsychotic drug treatment, and about a third reported ≥10 side effects. The high reporting rate may reflect a lack of formal follow-up by [general practitioners (GPs)] or the patient or that the [GPs] do not actively monitor side effects. Clinicians should be proactive in advising patients of the side effects and assisting them in seeking and managing them.] For people with dementia, an earlier review of antipsychotic side effects by a [generalist/dementia and mental health expert (MDT)] is recommended for people taking atypical antipsychotics." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with wounds?

"[This cohort had poorer health-related quality of life scores than a general cohort (HrQOL50)] (p = 0.0023). However, improvement in wound pain during treatment did not necessarily lead to improvement in HrQOL50 (p = 0.0317]. Both pre- and post-treatment wound pain levels were related to improvement in HrQOL50, indicating that it was not related to pain-free healing, but to the actual pain associated with the pain that could not heal without treatment." - Anonymous Online Contributor

Unverified Answer

What is treatment?

"Early postoperative drainage of exudate should be performed and antibiotic prophylaxis should be initiated. A multimodal therapy is recommended as a first-line treatment for metastatic breast cancer patients from a European randomised clinical trial. Treatments including chemotherapy, hormone therapy, targeted therapy, and surgery must be evaluated in prospective randomized trials in patients with resectable metastatic breast cancer in the metastatic setting." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for wounds?

"Clinicians are unlikely to be the first group to undertake a clinical trial for a chronic wound and they are likely to have low motivation to do so. They may be concerned that clinical trial results will have a limited impact on their care of a chronically wounded patient. Findings from a recent study provide a justification for conducting and evaluating small (20-40 participants) or cluster randomised trials to test the efficacy of wound healing interventions." - Anonymous Online Contributor

Unverified Answer

Has treatment proven to be more effective than a placebo?

"While there are still a limited number of RCTs testing out the effectiveness of acupuncture, there are four relevant RCTs found in the literature. In this review, the efficacy of acupuncture in alleviating pain associated with both simple and complex acute and chronic musculoskeletal pathology was demonstrated. However, while most studies have shown acupuncture to be more effective than a placebo, there was not a consensus among the studies that acupuncture was more effective than a placebo. Moreover, the conclusions of these studies could not be drawn with certainty due to flaws in each study. There is a need for further, well-designed RCTs to further investigate the effectiveness of acupuncture." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Spine Surgeries by sharing your contact details with the study coordinator.