Amputation Wound, Breast Cancer, Diabetes, Diabetic Foot, Incision Wound, Peripheral Arterial Disease, Surgical Wound
Conditions
Keywords
Infection, Dehiscence, Necrotic tissue, Surgical Revision, Scar tissue, Wound Closure
Brief summary
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.
Detailed description
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.
Interventions
Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
Sponsors
Study design
Eligibility
Inclusion criteria
* 18-85 years of age. Ability to provide informed consent. * Presence of a wound due to surgical intervention and closure. * Subject or responsible caregiver is willing and able to maintain the required offloading (as applicable for the location of the wound) and applicable dressing changes
Exclusion criteria
* Charcot Arthropathy Bilateral AK/BK amputation Active Drug/alcohol abuse (or history of drug/alcohol abuse in last 1 month) Dementia or impaired cognitive function Subjects with osteomyelitis or extreme gangrene. Excessive lymphedema Presence of active infection Subject has a history of or any intercurrent illnesses or conditions that would compromise the safety of the subject according to judgement of a qualified wound specialist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Unfavorable Wound Healing Outcomes at 4 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Wound | baseline and week 4 | Length of surgical closed wound was measured using camera . The unit is cm |
| Change in Skin Perfusion at Baseline and 4 Weeks | baseline to 4 weeks | skin perfusion will be assessed Skin Perfusion Pressure Test (SPP) |
| Change in Percentage of Tissue Oxygen Saturation From Baseline to 4 Weeks | baseline to 4 weeks | Tissue oxygen saturation was assessed by a non-invasive tissue oxygenation measurement system (Snapshot, Kent Imaging) |
| Self-reported Pain at Week 4 | week 4 | Pain will be assessed with visual analogue scale from 0 to 10 where 10 is the worst pain ever. |
| Reintervention | 4 weeks | The need for podiatric reintervention (e.g., wound reclosure due to wound adhesive failure) within 30 days of surgical wound closure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Control Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks. | 11 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Active | Control | Total |
|---|---|---|---|
| Age, Continuous | 64.4 years STANDARD_DEVIATION 10.6 | 64.6 years STANDARD_DEVIATION 9.1 | 64.5 years STANDARD_DEVIATION 9.9 |
| CKD (Chronic Kidney Disease) | 10 Participants | 4 Participants | 14 Participants |
| HbA1c | 9.4 % HbA1c STANDARD_DEVIATION 3.5 | 7.2 % HbA1c STANDARD_DEVIATION 0.8 | 8.6 % HbA1c STANDARD_DEVIATION 3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 8 Participants | 6 Participants | 14 Participants |
| Region of Enrollment United States | 20 Participants | 11 Participants | 31 Participants |
| Sex: Female, Male Female | 11 Participants | 2 Participants | 13 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
| Type of Surgery Revision of amputation site | 2 Participants | 0 Participants | 2 Participants |
| Type of Surgery Toe amputations | 17 Participants | 11 Participants | 28 Participants |
| Type of Surgery Transmetatarsal amputation | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 11 |
| other Total, other adverse events | 2 / 20 | 0 / 11 |
| serious Total, serious adverse events | 0 / 20 | 0 / 11 |
Outcome results
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.
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active | Number of Participants With Unfavorable Wound Healing Outcomes at 4 Weeks | 8 Participants |
| Control | Number of Participants With Unfavorable Wound Healing Outcomes at 4 Weeks | 7 Participants |
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)
Time frame: baseline to 4 weeks
Population: Only participants with available data at baseline and 4 weeks were included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Change in Percentage of Tissue Oxygen Saturation From Baseline to 4 Weeks | Baseline | 50 Percentage of tissue oxygen saturation | Standard Deviation 19.9 |
| Active | Change in Percentage of Tissue Oxygen Saturation From Baseline to 4 Weeks | 4 weeks | 50.6 Percentage of tissue oxygen saturation | Standard Deviation 14.3 |
| Control | Change in Percentage of Tissue Oxygen Saturation From Baseline to 4 Weeks | Baseline | 56 Percentage of tissue oxygen saturation | Standard Deviation 1.9 |
| Control | Change in Percentage of Tissue Oxygen Saturation From Baseline to 4 Weeks | 4 weeks | 50 Percentage of tissue oxygen saturation | Standard Deviation 21 |
Change in Skin Perfusion at Baseline and 4 Weeks
skin perfusion will be assessed Skin Perfusion Pressure Test (SPP)
Time frame: baseline to 4 weeks
Population: The data for some participants were not available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Change in Skin Perfusion at Baseline and 4 Weeks | Baseline | 62.2 mm Hg | Standard Deviation 18 |
| Active | Change in Skin Perfusion at Baseline and 4 Weeks | At 4 weeks | 63.1 mm Hg | Standard Deviation 20 |
| Control | Change in Skin Perfusion at Baseline and 4 Weeks | Baseline | 72.3 mm Hg | Standard Deviation 3.2 |
| Control | Change in Skin Perfusion at Baseline and 4 Weeks | At 4 weeks | 63.2 mm Hg | Standard Deviation 19.9 |
Length of Wound
Length of surgical closed wound was measured using camera . The unit is cm
Time frame: baseline and week 4
Population: Subjects with wound adhesive issues (e.g., wound re-opening) were excluded, and those with unavailable wound data at 4 weeks were not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Length of Wound | Baseline | 4.78 cm | Standard Deviation 3.36 |
| Active | Length of Wound | week 4 | 3.57 cm | Standard Deviation 2.92 |
| Control | Length of Wound | Baseline | 4.28 cm | Standard Deviation 3.11 |
| Control | Length of Wound | week 4 | 7.28 cm | Standard Deviation 2.92 |
Reintervention
The need for podiatric reintervention (e.g., wound reclosure due to wound adhesive failure) within 30 days of surgical wound closure.
Time frame: 4 weeks
Population: The data for one subject in the active group (out of the 20 subjects included) was unavailable.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active | Reintervention | 2 Participants |
| Control | Reintervention | 2 Participants |
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.
Time frame: week 4
Population: Only participants with available data at week 4 were included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Self-reported Pain at Week 4 | 2.09 units on a scale | Standard Deviation 3.27 |
| Control | Self-reported Pain at Week 4 | 2.25 units on a scale | Standard Deviation 1.98 |