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EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds

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ClinicalTrials.gov Identifier: NCT03960463
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
Electrochemical Oxygen Concepts, Inc.
Information provided by (Responsible Party):
Bijan Najafi, PhD, Baylor College of Medicine

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.


Condition or disease Intervention/treatment Phase
Surgical Wound Diabetes Amputation Wound Incision Wound Peripheral Arterial Disease Breast Cancer Diabetic Foot Device: Transcu O2® Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Oxygen Delivery With TransCu O2 to Study Success Rate of Surgically Closed Wounds
Actual Study Start Date : May 18, 2017
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : January 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active
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 randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.

No Intervention: Control
Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.



Primary Outcome Measures :
  1. Self-reported pain change at every week [ Time Frame: Baseline to 4 weeks ]
    Pain will be assessed with visual analogue scale from 0 to 10 where 10 is the worst pain ever.

  2. Change in skin perfusion at baseline and 4 weeks [ Time Frame: baseline to 4 weeks ]
    skin perfusion will be assessed Skin Perfusion Pressure Test (SPP)

  3. Change in wound size from baseline to 4 weeks [ Time Frame: baseline to 4 weeks ]
    wound size will be quantified using wound imaging systems

  4. Incidence of complication from baseline to 4 weeks [ Time Frame: baseline to 4 weeks ]
    Complication is described as infection, dehiscence, necrotic tissue

  5. Change in tissue oxygenation from baseline to 4 weeks [ Time Frame: baseline to 4 weeks ]
    Tissue Oxygenation will be assessed by a non-invasive tissue oxygenation measurement system (Snapshot, Kent Imaging)


Secondary Outcome Measures :
  1. Presence of scar tissue [ Time Frame: baseline to 4 weeks ]
    Scar presence will be assessed with imaging systems.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960463


Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Bijan Najafi, PhD    713-798-7536    bijan.najafi@bcm.edu   
Contact: Ana Enriquez, BS    7137987537    ana.enriquez@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
Electrochemical Oxygen Concepts, Inc.

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Responsible Party: Bijan Najafi, PhD, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03960463     History of Changes
Other Study ID Numbers: H-41361
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Bijan Najafi, PhD, Baylor College of Medicine:
Infection
Dehiscence
Necrotic tissue
Surgical Revision
Scar tissue
Wound Closure

Additional relevant MeSH terms:
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Wounds and Injuries
Diabetic Foot
Peripheral Arterial Disease
Peripheral Vascular Diseases
Surgical Wound
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases