EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds

Evaluation of Oxygen Delivery With TransCu O2 to Study Success Rate of Surgically Closed Wounds

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Diabetic Foot; Breast Cancer; Peripheral Arterial Disease; Surgical Wound; Amputation Wound; Incision Wound
• Intervention / Treatment: Device: Transcu O2®

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Electrochemical Oxygen Concepts, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2017
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): July 24, 2024

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Infection; Wound Closure; Dehiscence; Necrotic tissue; Surgical Revision; Scar tissue
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Foot Ulcer; Surgical Wound; Wounds and Injuries; Diabetic Foot; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: H-41361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No