Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03960463 |
Other study ID # |
H-41361 |
Secondary ID |
|
Status |
Recruiting |
Phase |
Phase 2/Phase 3
|
First received |
|
Last updated |
|
Start date |
May 18, 2017 |
Est. completion date |
December 15, 2024 |
Study information
Verified date |
January 2024 |
Source |
Baylor College of Medicine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.