Wounds and Injuries

All Conditions

Neoplasms

Rare Diseases

Precancerous Conditions

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.

LifeNet Health

Georgetown University

Chief, Division of Reconstructive Plastic Surgery

Symptoms and General Pathology

Head and Neck Neoplasms

Ulcer

Anti-Infective Agents

All Drugs and Chemicals

Gastrointestinal Agents

Anti-Bacterial Agents

Carboxymethylcellulose Sodium

Laxatives

Cathartics

Silver, in its common ionic (active) form (Ag+), is particularly attractive as an antibacterial agent because it can be readily incorporated into dressing materials. Silver-dressing are wound products designed to control infection and provide a wound environment conducive to management exudates, pain, and malodour.

Experimental group are accepted primary dressing the AQUACEL Ag. control group are provided with the AQUACEL on the wound surface. Wound specialist or primary nurses undertaking wound care are informed by inclusion criteria that the treatment shall be adhered to during the two-week study period.All wounds are cleansed with sterile saline prior to assessment and dressing application.The sterile, non-woven sodium carboxymethylcellulose primary AQUACEL Ag with 1.2% ionic silver.Each secondary dressing is covered a sterile gauze.Dressings are changed between daily assessments when judged necessary.Patients attended the wound ward weekly for treatment evaluation. All participating clinics used the same wound management guidelines and data collection forms.

silver-releasing dressings

We-Yu Hu

Background. Malignant fungating wounds(MFW) are caused by cancerous cells invading skin tissue, which exhibit increased bacterial burdens that not only result in a negative physical impact (odour, exudates, pain, and infection) on patients, impairing their quality of life, but they also increase treatment costs. A systematic review of the effectiveness of that the silver-releasing dressing in the management of infected chronic wounds can help enhance control of wound bed infection and inflammation, tissue management, moisture balance, and protect wound edge. However, few studies have examined the effects on people with MFW.

Hypothses In this study that the hypothesized that cancer patients in the ionic silver dressing group will perception higher quality of life compared to patients in the control group who receive non-ionic silver dressing. In addition, we hypothesized that cancer patients who also receive ionic silver dressing will have lower level of symptom distress at end of study compared to patients in the control group receive non-ionic silver dressing care.

Introduction. At the beginning of the 21st century, cancer is increasing in the aging population and patients often have a greater life expectancy than they did 40 years ago (Payne et al 2004). As people age, and the incidence of cancer increases, it is essential to push the frontiers of oncology care to meet the symptom management needs of these patients. For many, cancer has become a slowly progressive, chronic disease - a change that brings with it particular challenges for oncology nurses (Hoskin and Makin 1998). A systematic review of the effectiveness of that the silver-releasing dressing in the management of infected chronic wounds can help enhance control of wound bed infection and inflammation, tissue management, moisture balance, and protect wound edge. This study is designed to assess the effects of ionic silver dressing (AQUACEL Ag) in head and neck patients with malignant fungating wound (MFW) on the quality of life, symptom distress and wound bed changed of patients with MFW

Definition of MFW. Malignant Fungating wounds arise as a result of infiltration of the structures of the skin by malignant cells. These cells may arise from primary skin cancer, an underlying malignant tumor or through metastasis spread from a distant malignant tumor(Punder, 1998).A fungating cancer is a primary or secondary malignant growth in the skin which has ulcerated and results in pain, exudates, bleeding, infection and malodour(Twycross, 1995) .A malignant tumor will invade and destroy adjacent tissues and can spread to other tissues with in cells that break off and travel in the blood or lymph system. It can develop its own blood supply, sometime outgrowing it and causing the tumor to become necrotic in the middle(Mera, 1997).Dealey(1994) states that, as the tumor extends, capillaries rupture, leading to epithelium results in ulceration through the skin, and lesions presents as a fungating, foul-smelling mass(Daeley, 1994).Fungating malignant wounds are caused by the infiltration of the skin and its supporting blood and lymph vessels by a local tumor or as a result of metastasis growth from the primary tumor. Unless the malignant cells are checked by single or combination cancer treatments the fungation extends with the potential for causing massive damage at the wound site through a combination of proliferate growth, loss of vascularity and ulceration(Mortimer, 1998) .A fungating wound is defined as a cancerous lesion involving the skin, which is open and may be draining. The lesion may be result of a primary cancer or metastasis to the skin from a local tumor or from a tumor in a distant site. It may take the form of a cavity, an open area on the surface of the skin, skin nodules, or a nodular growth extending from the surface of the skin(British Columbia Cancer Agency, 2001) .As the malignant cells multiply in the skin they form a tumour that enlarges causing disruption of skin capillaries and lymph vessels, eventually leading to tissues Hypoxia and subsequent skin necrosis.

Infection control of MFW. All chronic wounds contain bacteria. Kingsley(2003) state that the change in numbers of bacteria and the body's response as a continuum, rating from contamination to infection(Kingsley, 2003). Contamination is mean that the bacteria present on the wound surface but are not proliferating and have no clinic effect; colonised imply bacteria have proliferated, but there is no host reaction; critical colonisation occurs where the body's local host response starts to be initiated, but there are no systemic sign of infection; Infection is point in time when the bacteria have multiplying and invaded deeper tissues, healing is impaired and produced a systemic host reaction(Jacqui. Fletcher, 2005; Verdu Soriano , Rueda Lopez, Martinez Cuervo, \& Soldevilla Agreda 2004) .

Clinical recognition of these rating stages is not easy because there are no clear descriptors. However, Soriano et al (2004) defined classification according to the number of bacteria present in the wound bed: Contamination-≦103 colony-forming unit (CFUs) per gram of tissues; colonised -≦104 CFUs ; Infection -≧105 CFUs. Cutting and White noted several aspects of wound infection such as: serous drainage with concurrent inflammation, discoloured granulation tissue, pocketing at the wound base, unexpected pain , foul odour, increase in exudates, exudates that becomes purulent instead of serous, and wound breakdown(White \& Cutting, 2006).

In the MFW, the presence of hypoxic necrotic tissues within the wound provides an excellent medium for growth of aerobic and anaerobic bacteria(J. Clark, 2002). Anaerobic and aerobic bacteria thrive in these conditions, giving rise to excessive malodour wound exudates(Haisfield-Wolfe \& Rund 1997). Lo et al (2006) survey of seventy cancer patients with MFW in Taiwan, the study found that the 60.3% wound bed presented necrotic tissue ; malodour was present in 50% of patients ; 81.4% shows moderate to large exudates and 71.4% reported purulent(Lo, 2006). According above the data, infection has emerged as a major health problem during the patient suffers MFW.

Ionic silver dressing. Silver, in its common ionic (active) form (Ag+), is particularly attractive as an antibacterial agent because it can be readily incorporated into dressing materials. When the materials contact an aqueous environment, the silver complex contained in them is dissociated (Ovington 2004, White \& Cutting 2006). The mechanism of action for Ag+ is that it binds to bacterial cell DNA, and enzymes, and proteins in the cell wall. Once the silver cation attaches to these sites, it alters their structure, resulting in structural and functional changes in the bacterial cell (Ovington 2004).It is suggested by numerous authors that silver dressings should be utilized when critical colonization within a wound occurs (Ovington 2004, White \& Cutting 2006, Lo et al 2008). Therefore, this study research questions is (1)What are the effects of ionic silver dressing (AQUACEL Ag)in head and neck patients with malignant fungating wound, as compared to hydrofiber dressing(AQUACEL), on the individual perception subjective quality of life?(2) What are the effects of ionic silver dressing (AQUACEL Ag) in head and neck patients with malignant fungating wound, as compared to hydrofiber dressing (AQUACEL) alone, on the symptom distress and wound bed changed of patients receiving ionic silver dressing (AQUACEL Ag) for cancer patients?

The Effect on an Ionic Silver Dressing in Head and Neck Patients With Malignant Fungating Wound

National Taiwan University Hospital

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Patient diagnosed with soft tissue sarcoma and receiving preoperative radiotherapy.

Ralph DaCosta, PhD

Peter Ferguson, MD

The investigators have recently developed an innovative optical molecular imaging platform (called PRODIGI) based on high-resolution fluorescence and white-light technologies in a hand-held, real-time, high-resolution, non-invasive format. PRODIGI offers a non-contact means of obtaining instantaneous image-based measurements of diagnostically-relevant biological and molecular information of a wound and surrounding skin tissues for the first time and could have significant impact on improving conventional wound care, management, and guidance of intervention. In preliminary preclinical testing, the investigators have discovered that when wounds are illuminated by violet/blue light, endogenous collagen in the connective tissue matrix emit a characteristic green fluorescent signal, while most pathogenic bacterial species emit a unique red fluorescence signal due to the production of endogenous porphyrins. Therefore, with autofluorescence imaging, no exogenous contrast agents are needed during imaging, making this approach particularly appealing as a diagnostic imaging method for clinical use.

In the context of this study, PRODIGI is used to assess wound complications in patients diagnosed with soft tissue sarcoma and treated with pre-operative radiotherapy. Both pre- and postoperative external beam radiotherapy combined with limb salvage surgery have similarly high rates of local control in the management of extremity soft tissue sarcoma. The main acute side effect associated with preoperative radiotherapy is wound healing complications. Wound care overall is a major clinical challenge and presents an enormous burden to health care worldwide. The objective of this clinical study is to determine if PRODIGI coupled with an optical tracking platform has clinical utility in identifying, quantitatively measuring and longitudinally tracking bacterial imbalance on the patient's intact skin surface at the location of the surgical resection site for adult patients with lower limb soft tissue sarcoma treated with preoperative intensity-modulated radiation therapy and limb salvage surgery and, further, to investigate whether this bacterial imbalance is related to radiotherapy dose and wound complications.

Optical Tracking System

For this study, PRODIGI was combined with a commercial optical tracking system (OTS, Polaris, NDI Medical, Waterloo, Ontario, Canada) to track the movement of the device in space relative to a patient over time. This addition is in the form of an infrared-light camera, which tracks four IR reflective spheres (NDI Medical, Waterloo, Ontario, Canada) that are fixed to the external housing of PRODIGI device.

The OTS has been described previously. Briefly, it consists of optical tracking technology, which provides 6 degrees of freedom (x, y, z, pitch. yaw, roll), attached to the camera along with software developed in house to register and visualize the tracked camera pose relative to a previously acquired radiological volumetric image data. The in-house software platform GTxEyes performs tracking and navigation of the imaging camera, camera calibration (including any image distortion), registration of the camera coordinates with respect to the CT images, and co-visualization (e.g. visual overlay) of the camera and CT images. Radiation dose planning information can also be spatially co-registered and overlaid with the hybrid optical-CT images/videos using methods described previously by our group.

After loading a CT image of the patient, the OTS is registered to the CT coordinate space by identification of known fiducials using a conventional pointer tool. With registration complete, the coordinates of the PRODIGI camera can be tracked in real time relative to the CT image. Viewing options include orthogonal views through the CT image, corrected PRODIGI image and a virtual image based on the CT surface rendering viewed from the perspective of a virtual camera at the PRODIGI coordinates. Radiation dose can be displayed on the real and virtual camera views as either isodose lines or colorwash.

Patient Population

Patients will be recruited from the Princess Margaret Cancer Centre, University Health Network (Ontario, Canada) sarcoma clinic to be treated with pre-operative external beam RT followed by surgical resection of lower limb soft-tissue sarcoma. Informed consent was obtained according to institutional Research Ethics Board (REB) requirements and Good Clinical Practice (GCP) (ClinicalTrials.gov NCT02270086). Patients with pre-existing skin issues, who received prior radiotherapy or required chemotherapy were not eligible to the study.

Imaging Procedures

At the radiotherapy planning stage, a CT scan of the patient sarcoma site is acquired for standard treatment planning purposes. Prior to the CT scan, small radio-opaque fiduciary markers (Suremark TM skin marking labels) were placed on the patient's six radiation treatment setup points, making the \<1 mm diameter points easy to identify in the CT images. After the CT scan, these markers were replaced with ink tattoos and used during radiation treatment to align the patient with radiation therapy machine reference frame. In addition to the CT fiducial markers placed at the treatment setup points, a flexible radio-opaque wire was overlaid on the planned surgical incision. This enabled localization of the entire surgical scar during the radiation treatment plan procedure. A radiotherapy stereotactic mask was also made at that stage. Following CT simulation scan acquisition, an appropriate radiotherapy plan was designed as per institutional clinical standard guidelines.

Imaging with PRODIGI and the OTS was performed throughout the sarcoma management, i.e. during radiotherapy and in the operating room. Imaging was performed at three time points during RT: fractions 0, 12 and 25, i.e. at the beginning, middle and end of the treatment. Four out of six treatment setup points marked with radio-opaque fiduciary markers on the CT scans were used to perform the optical to CT co-registration. An optically-tracked pointer tool using four IR reflective spheres (identical to the ones fixed to the PRODIGI system) was used to register the patient in space with respect to the IR camera. For this, the pointer was placed sequentially on each tattoo mark, identified and spatially registered by the tracking IR camera and visualized in real-time on the CT scans using the custom-built software GTxEyes. The locations of the tattoo points in the optical tracking coordinate system were then registered to the corresponding points in the CT image using the fiduciary CT markers. Once registration was completed, the planned surgical scar was drawn on the patient's skin with a marker by superimposing the optically-tracked pointer on the scar visible on the CT scans. An imaging session consisted of both WL and corresponding AF imaging of the planned skin surgical incision and surrounding tissue. Room lights were turned off during AF imaging to avoid background signal and artifacts. The four reflective spheres on the PRODIGI device were pointed towards the IR camera to ensure proper tracking in 3D during the entire session.

To perform PRODIGI imaging in the operating room, a sterilization method approved by UHN's control and processing department using a sterile drape was found to be the most effective way to ensure proper sterile conditions without damaging the instrument or affecting its performance. An elongated sterile drape (Cardinal Health Canada, 29-59029) was used to cover the entire PRODIGI imaging system, i.e. the camera and electrical power cord. Six strong neodymium magnets (Super Magnets, 8 mm diameter) were embedded into the emission filter slider and six corresponding magnets were autoclaved prior to each use and placed on the outside of the drape to hold it in place to avoid image quality degradation. Steri-strips (3M, R1547) were applied on the outside of the draped device to tighten the drape around the IR reflective spheres to insure adequate tracking during imaging. Imaging was performed at five time points: before and after sterilization of the surgical site (OR1, OR2), once the flap was raised (OR3), after tumor excision (OR4) and after closure (OR5).

The combined WL and AF images were part of a superset of data recorded using the tracking system. The superset also included preoperative patient CT and the patient's RT dose volume. A skin surface model was generated from the patient's CT, where each surface point held a quantitative tuple that contained the surface normal vector, the RT dose, the WL scalar, the AF scalar, and the camera pose corresponding to the AF scalar. Overlay of WL and AF images on the skin surface model was visualized using the software ParaView.

Evaluating Bacterial Response in Sarcoma Management Using Fluorescence Imaging

Evaluating Bacterial Response Throughout Sarcoma Management Using An Optically Tracked, Hand-Held Fluorescent Imaging Device

Data will be presented in a peer-reviewed journal at completion of study

Microbiology swabbing will be performed during radiotherapy treatments (3 visits), surgery (1 visit) and follow-up appointments (3-6 visits depending on wound healing) to monitor changes in bacterial presence

Wound complication is identified 6-8 weeks after surgery, i.e. normal time frame for complete closure of surgical incision

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
The Effect on an Ionic Silver Dressing in Head and Neck Patients With Malignant Fungating Wound	NCT00813631	Head and Neck N... Head and Neck C... Wounds Ulcer	silver-releasin...	18 Years -	National Taiwan University Hospital
Evaluating Bacterial Response in Sarcoma Management Using Fluorescence Imaging	NCT02270086	Soft Tissue Sar... Wounds		18 Years -	University Health Network, Toronto
Evaluating Bacterial Response in Sarcoma Management Using Fluorescence Imaging	NCT02270086	Soft Tissue Sar... Wounds		18 Years -	University Health Network, Toronto
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

Spots Global Cancer Trial Database for wounds

Every month we try and update this database with for wounds cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for wounds

Every month we try and update this database with for wounds cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for wounds cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.