EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds

NCT ID: NCT03960463

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-18
• Study Completion Date: 2024-07-24

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.

Conditions

Surgical Wound; Diabetes; Amputation Wound; Incision Wound; Peripheral Arterial Disease; Breast Cancer; Diabetic Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Active

Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care.

Group Type: ACTIVE_COMPARATOR

Transcu O2®

Intervention Type: DEVICE

Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.

Control

Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transcu O2®

Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Electrochemical Oxygen Concepts, Inc.

INDUSTRY

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Bijan Najafi, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H-41361

Identifier Type: -

Identifier Source: org_study_id