EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds

NCT03960463 | Completed Results FDA Device

• 1 other identifier: H-41361
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Infection; Dehiscence; Necrotic tissue; Surgical Revision; Scar tissue; Wound Closure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Length of Wound

  baseline and week 4

• Change in Skin Perfusion at Baseline and 4 Weeks

  baseline to 4 weeks

• Change in Percentage of Tissue Oxygen Saturation From Baseline to 4 Weeks

  baseline to 4 weeks

• Self-reported Pain at Week 4

  week 4

• Reintervention

  4 weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

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

Device: Transcu O2®

Control

NO INTERVENTION

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

Interventions

Transcu O2® DEVICE

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

Active

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Electrochemical Oxygen Concepts, Inc.: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Surgical Wound; Diabetes Mellitus; Peripheral Arterial Disease; Breast Neoplasms; Diabetic Foot; Infections; Cicatrix

Condition Hierarchy (Ancestors)

Wounds and Injuries; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Foot Ulcer; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetic Neuropathies; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bijan Najafi
• Organization: Baylor College of Medicine

bijan.najafi@bcm.edu

7137987536

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: May 18, 2017
• Primary Completion: December 15, 2023
• Study Completion: July 24, 2024
• Last Updated: January 23, 2025
• Results First Posted: January 23, 2025

Record last verified: 2024-12

Locations

US (1)