An interventional study of Transcu O2® in Surgical Wound, Diabetes and Amputation Wound, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Supportive care
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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This study's enrollment of 33 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
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Exclusion Criteria:
Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care.
Device: Transcu O2®
Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.
Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
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
Length of Wound
Length of surgical closed wound was measured using camera . The unit is cm
Time frame: baseline and week 4
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
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
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
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
| Milestone | Active | Control |
|---|---|---|
| Started | 22 | 11 |
| Completed | 20 | 11 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
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.
| Participants | Active | Control |
|---|---|---|
| Number of Participants With Unfavorable Wound Healing Outcomes at 4 Weeks | 8 | 7 |
Length of surgical closed wound was measured using camera . The unit is cm
| cm | Active | Control |
|---|---|---|
| Baseline | 4.78 ± 3.36 | 4.28 ± 3.11 |
| week 4 | 3.57 ± 2.92 | 7.28 ± 2.92 |
skin perfusion will be assessed Skin Perfusion Pressure Test (SPP)
| mm Hg | Active | Control |
|---|---|---|
| Baseline | 62.2 ± 18 | 72.3 ± 3.2 |
| At 4 weeks | 63.1 ± 20 | 63.2 ± 19.9 |
Tissue oxygen saturation was assessed by a non-invasive tissue oxygenation measurement system (Snapshot, Kent Imaging)
| Percentage of tissue oxygen saturation | Active | Control |
|---|---|---|
| Baseline | 50 ± 19.9 | 56 ± 1.9 |
| 4 weeks | 50.6 ± 14.3 | 50 ± 21 |
Pain will be assessed with visual analogue scale from 0 to 10 where 10 is the worst pain ever.
| units on a scale | Active | Control |
|---|---|---|
| Self-reported Pain at Week 4 | 2.09 ± 3.27 | 2.25 ± 1.98 |
The need for podiatric reintervention (e.g., wound reclosure due to wound adhesive failure) within 30 days of surgical wound closure.
| Participants | Active | Control |
|---|---|---|
| Reintervention | 2 | 2 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active | 0/20 (0%) | 0/20 (0%) | 2/20 (10%) |
| Control | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Event | Active | Control |
|---|---|---|
| Non-Study Related Adverse EventGeneral disorders | 2/20 | 0/11 |
| Age, Continuous(years) | Active | Control | Total |
|---|---|---|---|
| Mean | 64.4 ± 10.6 | 64.6 ± 9.1 | 64.5 ± 9.9 |
| Sex: Female, Male(Participants) | Active | Control | Total |
|---|---|---|---|
| Female | 11 | 2 | 13 |
| Male | 9 | 9 | 18 |
| Race (NIH/OMB)(Participants) | Active | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 3 | 10 |
| White | 8 | 6 | 14 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Region of Enrollment(Participants) | Active | Control | Total |
|---|---|---|---|
| United States | 20 | 11 | 31 |
| CKD (Chronic Kidney Disease)(Participants) | Active | Control | Total |
|---|---|---|---|
| Count of participants | 10 | 4 | 14 |
| HbA1c(% HbA1c) | Active | Control | Total |
|---|---|---|---|
| Mean | 9.4 ± 3.5 | 7.2 ± .8 | 8.6 ± 3.0 |
| Type of Surgery(Participants) | Active | Control | Total |
|---|---|---|---|
| Toe amputations | 17 | 11 | 28 |
| Transmetatarsal amputation | 1 | 0 | 1 |
| Revision of amputation site | 2 | 0 | 2 |
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