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| Name | Class |
|---|---|
| Electrochemical Oxygen Concepts, Inc. | INDUSTRY |
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The investigators will test the efficacy of the novel oxygen diffusion dressing allows delivery tissue oxygenation via TransCu O2® Oxygen Delivery System for use in caring for patients with surgically closed wounds.
The investigators hypothesize that using this novel oxygen diffusion dressing will reduce the likelihood of necrotic tissue as well as severe incisional scar post-surgical closure by improving transcutaneous oxygen levels during wound healing process. TransCu O2 Oxygen Delivery System is a novel wound healing therapy that promises to enhance tissue hydration, which in turn may lead to quick epithelialization essential to reduce the likelihood of formation of necrotic tissue and excessive scars.
Surgical wound (e.g., post minor amputation, reconstruction surgery, or surgical incision) complications such as infection, dehiscence, necrotic tissue, surgical revision, and poor cosmesis are unfortunately highly prevalent in patients undergoing surgical interventions. In most cases surgical wounds are managed with a simple island dressing, orthopaedic wool padding and a light retention bandage. It could be argued that such low cost, traditional dressings are adequate for most surgical wounds. However, some patients with poor tissue integrity often require modern wound care products that offer additional benefits, in particular among those with vascular and poor tissue oxygenation problem. Poor tissue oxygenation and poor skin perfusion could lead to surgical wound complications such as wound infection, tissue necrosis, phantom pain, trauma and untimely surgical revision as well as major amputation.
In particular, the presence of non-viable, necrotic tissue (estimated to occur in 15-25% of cases) is significant as it can be responsible for delaying healing, prolonging the inflammatory response, mechanically obstructing contraction and impeding re-epithelialisation. It also provides a focus for wound infection and surgical revision.
The problem associated with necrotic tissue is not limited to limb amputation and could be seen in other surgical closures leading to excessive scar formation. Many of these scars can be problematic, being aesthetically unpleasant and causing discomfort. Blood supply is a significant factor in wound healing, and an area of the skin with rich supply of vasculature is known to heal to finer scars. Several studies have demonstrated that mild hypoxia (lack of transcutaneous oxygen) is present in early scars, moderate hypoxia in proliferative scars, and severe hypoxia in regressive scars. Oxygen levels then return to normal in mature scars, which is consistent along with the dynamic change in microvessel density. Therefore level of transcutaneous oxygen could be a determinant factor in formation of excessive scar formation.
Dressing materials are known to influence postoperative surgical wound healing and scar formation. A particular dressing that could promote wound hydration is key to ensure quick epithelialization and decrease excessive scar formation. The current standard of care in wound healing is to promote a moist wound environment by regular changing dressing and hydrate wound when needed. Some new advanced dressing and products have been also suggested with promising results in reducing excessive scar formation such as the use of silicone sheeting, hydrogel wound dressing, etc.
In this study, the investigators hypothesize that using novel oxygen diffusion dressing allows delivery tissue oxygenation via TransCu O2® Oxygen Delivery System will reduce the likelihood of necrotic tissue as well as severe incisional scar post-surgical closure by improving transcutaneous oxygen levels during wound healing process. TransCu O2 Oxygen Delivery System is a novel wound healing therapy that promises to enhance tissue hydration, which in turn may lead to quick epithelialization essential to reduce the likelihood of formation of necrotic tissue and excessive scars.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care. |
|
| Control | No Intervention | Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcu O2® | Device | Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Unfavorable Wound Healing Outcomes at 4 Weeks | Unfavorable wound healing outcomes were defined as the occurrence of one or more of the following conditions : infection, wound dehiscence, or necrotic tissue, as documented in the patient chart up to 4 weeks after the surgical wound closure. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Wound | Length of surgical closed wound was measured using camera . The unit is cm | baseline and week 4 |
| Change in Skin Perfusion at Baseline and 4 Weeks | skin perfusion will be assessed Skin Perfusion Pressure Test (SPP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care. Transcu O2®: Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks. |
| FG001 | Control | Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care. Transcu O2®: Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Unfavorable Wound Healing Outcomes at 4 Weeks | Unfavorable wound healing outcomes were defined as the occurrence of one or more of the following conditions : infection, wound dehiscence, or necrotic tissue, as documented in the patient chart up to 4 weeks after the surgical wound closure. | Posted | Count of Participants | Participants | 4 weeks |
|
AEs were collected from study start date to the study completion date in a non-systematic way. Per patient, AEs were collected up to 4 weeks after baseline. During follow-ups, participants were asked if they experienced AEs. If participant missed a visit or had low adherence the coordinator called the participant and asked for AEs. AEs were also reported by the participants on a case-by-case basis when they occurred.
The clinicaltrials.gov definitions were used. We collected unfavorable medical occurrences experienced by study participants and noted whether they were study device related (caused directly by the device), unrelated to the study device, or whether it was caused by improper device usage. This information was collected non-systematically and not separately -- either participants reported events directly or during phone calls/study visits study coordinators asked about issues.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care. Transcu O2®: Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Study Related Adverse Event | General disorders | Non-systematic Assessment | 1 participant had their wound reopen after trauma to wound site (unrelated to study device) 1 participant had severe bleeding unrelated to study device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bijan Najafi | Baylor College of Medicine | 7137987536 | bijan.najafi@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2023 | Jul 24, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D003920 | Diabetes Mellitus |
| D058729 | Peripheral Arterial Disease |
| D001943 | Breast Neoplasms |
| D017719 | Diabetic Foot |
| D007239 | Infections |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| baseline to 4 weeks |
| Change in Percentage of Tissue Oxygen Saturation From Baseline to 4 Weeks | Tissue oxygen saturation was assessed by a non-invasive tissue oxygenation measurement system (Snapshot, Kent Imaging) | baseline to 4 weeks |
| Self-reported Pain at Week 4 | Pain will be assessed with visual analogue scale from 0 to 10 where 10 is the worst pain ever. | week 4 |
| Reintervention | The need for podiatric reintervention (e.g., wound reclosure due to wound adhesive failure) within 30 days of surgical wound closure. | 4 weeks |
| Control |
Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported. | Count of Participants | Participants |
|
| Race (NIH/OMB) | We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| CKD (Chronic Kidney Disease) | Diagnosis of CKD was unknown for two of participants out of 20 | Count of Participants | Participants |
|
| HbA1c | Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported. | Mean | Standard Deviation | % HbA1c |
|
| Type of Surgery | Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported. | Count of Participants | Participants |
|
|
|
| Secondary | Length of Wound | Length of surgical closed wound was measured using camera . The unit is cm | Subjects with wound adhesive issues (e.g., wound re-opening) were excluded, and those with unavailable wound data at 4 weeks were not included | Posted | Mean | Standard Deviation | cm | baseline and week 4 |
|
|
|
| Secondary | Change in Skin Perfusion at Baseline and 4 Weeks | skin perfusion will be assessed Skin Perfusion Pressure Test (SPP) | The data for some participants were not available | Posted | Mean | Standard Deviation | mm Hg | baseline to 4 weeks |
|
|
|
| Secondary | Change in Percentage of Tissue Oxygen Saturation From Baseline to 4 Weeks | Tissue oxygen saturation was assessed by a non-invasive tissue oxygenation measurement system (Snapshot, Kent Imaging) | Only participants with available data at baseline and 4 weeks were included | Posted | Mean | Standard Deviation | Percentage of tissue oxygen saturation | baseline to 4 weeks |
|
|
|
| Secondary | Self-reported Pain at Week 4 | Pain will be assessed with visual analogue scale from 0 to 10 where 10 is the worst pain ever. | Only participants with available data at week 4 were included | Posted | Mean | Standard Deviation | units on a scale | week 4 |
|
|
|
| Secondary | Reintervention | The need for podiatric reintervention (e.g., wound reclosure due to wound adhesive failure) within 30 days of surgical wound closure. | The data for one subject in the active group (out of the 20 subjects included) was unavailable. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | Control | Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks. | 0 | 11 | 0 | 11 | 0 | 11 |
|
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| D004700 | Endocrine System Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Revision of amputation site |
|