Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Pain

Chest Pain

Precancerous Conditions

Neurologic Manifestations

All Drugs and Chemicals

Bone Density Conservation Agents

Calcium

Calcium, Dietary

Imidacloprid

The participants in the intervention group will be provided with extended information of the advantages of the CT examination of the heart's arteries. This will be given to the participants both orally and written in form of a leaflet. In addition will they be given the opportunity for a visual go-through of their own calcium score images. After this they will be informed of the normal examination result.

The extended information consists out of an information leaflet and a visual go-through of the participants calcium score images. The patients are then given the normal examination result.

Extended information

Tone M Norekvaal, Professor

Chest pain is a common cause of visits in the Emergency Room and General Practice, and is most commonly connected as a symptom of coronary disease, as for instance angina pectoris and acute myocardial infarct. Approximately 75-80% of these patients are not diagnosed with coronary disease or other cardiac findings. However, many of these patients still report chest pain and worries about cardiac disease.

This study is based on patients that are referred to a CT-examination of the coronary arteries on the background of chest pain, where the CT-examination shows normal coronary arteries.

The study aims to evaluate whether providing an intervention to this group of patients has an effect on patient satisfaction, patient's worry of cardiac disease and incidence of chest pain.

The intervention group will be compared with a similar group going through the same CT-examination, but is receiving the examination result from their regular general practitioner (RGP), which is considered standard care.

The hypothesis is that patients with chest pain with no coronary findings receiving extended information before getting the normal examination results experience a better patient satisfaction than those receiving the examination result from their RGP.

This study is a randomized controlled study. Eligible patients going through a CT-examination of the heart's coronary arteries, Coronary CT Angiogram (CCTA) will after an informed consent be randomized into two groups, either the intervention group or standard care.

The intervention consists of extended information regarding the benefits of doing a CCTA, thereby emphasising the specificity and accuracy of the CCTA's ability to exclude coronary disease. After this, there will be given an opportunity of a visual go-through and explanation of CT-images. Then they will be informed of the examination result that shows normal coronary arteries.

Follow up is planned after one month, six months and twelve months, where the participants receive the same questionnaire as at baseline to fill out and return. The questionnaire consists of Seattle Angina Questionnaire and RAND-12, in addition to social demographic and clinical data, such as sex, height, weight and current medication.

Providing Patient Information and CT Examination Results

Providing Patients With Extended Information and Examination Results Immediately After a Diagnostic CT of the Coronary Arteries

Our primary outcome is to examine whether patients with chest pain with normal coronary arteries experience greater satisfaction with their treatment if they receive extended information and the examination results immediately after the CT examination than those who receive the examination result from their RGP.

This is measured with 2 single items in Seattle Angina Questionnaire regarding satisfaction with treatment. Values range from 1-5, 1 is the lowest level of satisfaction, and 5 is the highest level of satisfaction. Greater satisfaction with treatment will be defined by a higher score at follow-up after 1 month.

In addition, there is a separate question of patients' trust in the CT examination measured with a VAS-scale , ranging from 1-10, 1 represents lowest possible degree of trust, and 10 represents highest possible degree of trust. Greater trust in the CT-examination is defined by higher scores at follow-up after 1 month.

To examine if patients report less worry of having a heart attack or sudden death after having a CT examination of the heart's arteries, when receiving extended information and the normal examination result immediately after the CT examination.

This is measured with a single item in Seattle Angina Questionnaire regarding worry of having heart attack or die suddenly. Values range from 1-5, 1 represents "worry all the time" and 5 represents "never worry". Less worry of having a heart attack or die suddenly will be defined by higher scores at follow-up after 1, 6 and 12 months.

To examine if patients with chest pain with normal coronary arteries report less chest pain and/or less use of health care services if they receive extended information and the examination results immediately after the CT examination compared to those who receive the examination result from their RGP.

This is measured with 2 single items in Seattle Angina Questionnaire. One item regards limitations in everyday activities because of chest pain. Values range from 1-5, 1 represents lowest level, and 5 represents highest level of function. The second item is about incidence of chest pain the last week. Values range from 1-5, 1 represents high incidence of chest pain and 5 represents no chest pain. Less chest pain is associated with higher scores at all times of follow up, compared to baseline.

In addition, clinical data regarding participants use of primary and secondary health care the last 4 weeks is collected at all times of follow-up and is compared to baseline data.

To examine whether patients with chest pain with normal coronary arteries experience greater satisfaction with their treatment if they receive extended information and the examination results immediately after the CT examination than those who receive the examination result from their RGP.

This is measured with 2 single items in Seattle Angina Questionnaire regarding satisfaction with treatment. Values range from 1-5, 1 is the lowest level of satisfaction, and 5 is the highest level of satisfaction. Greater satisfaction with treatment will be defined by a higher score at follow-up after 6 and 12 months.

Haukeland University Hospital

Wounds and Injuries

Rare Diseases

Chronic Graft Versus Host Disease

Integra® is a bilayer wound matrix made out of bovine tissue.

DermACELL® is a bilayer wound matrix made out of human tissue.

DermACELL® is a bilayer wound matrix made out of human tissue and is applied to the wound in standard of care fashion.

DermACELL®

Integra® is a bilayer wound matrix made out of bovine tissue and is applied to the wound in standard of care fashion.

Integra®

Christopher Attinger, MD

Both DermACELL® and Integra® Bilayer Wound Matrix are indicated for deep soft tissue coverage and serve as a biological matrix for cellular migration. The current thinking about the utility of these products is to apply over the wound surface and wait until the graft is well vascularized (granular bed/neodermis). At that point a split thickness skin graft can be applied over this area to cover and heal the wound. This study will determine whether human allograft or xenograft will create a durable neodermis that is more supportive of accepting of a split thickness skin graft. Patients who do not receive Split thickness skin grafts will be assigned to the second cohort for observation of healing rates.

This is a prospective, randomized, single site, clinical research trial comparing the clinical outcomes of DermACELL® compared with Integra® Bilayer Wound Matrix in dermal regeneration. A total of 100 subjects will be randomized into either the DermACELL® (n=50) or Integra® Bilayer Wound Matrix (n=50) treatment group. An interim analysis will be performed when both groups have enrolled 25 subjects. Subjects will receive either DermACELL® or Integra® Bilayer Wound Matrix in the operating room for coverage of deep soft tissue defects in the lower extremity. Subjects will then be followed in the outpatient clinic. Once the neodermis has been sufficiently generated, a split thickness skin graft (autograft or allograft) will be applied in the operating room. The split thickness skin graft application site will be then followed to observe viability.

Photographs are submitted and evaluated by a blind, independent assessor.

Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix

A Randomized, Prospective Trial Comparing the Clinical Outcomes for DermACELL® Compared With Integra® Bilayer Wound Matrix

The percent of split thickness skin graft (autograft or allograft) take for a wound that receives DermACELL® as compared with Integra® Bilayer Wound Matrix 30 days after split thickness skin graft application.

Time (days) required for wound bed preparation (granular bed) for the application of a split thickness skin graft (autograft or allograft) after placement of DermACELL® as compared with Integra® Bilayer Wound Matrix.

The percent of subjects with complete split thickness skin graft (autograft or allograft) take utilizing DermACELL® as compared with Integra® Bilayer Wound Matrix 30 days after split thickness skin graft application.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Providing Patient Information and CT Examination Results	NCT03781661	Chest Pain Nonmalignant Co...	Extended inform...	18 Years - 80 Years	Haukeland University Hospital
Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix	NCT03285698	Wounds Chronic Wounds Nonmalignant Co...	DermACELL® Integra®	18 Years - 90 Years	Georgetown University
Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix	NCT03285698	Wounds Chronic Wounds Nonmalignant Co...	DermACELL® Integra®	18 Years - 90 Years	Georgetown University

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