Continuous Diffusion of Oxygen Treatment for Incision Wounds

NCT04307355 | Completed Results FDA Device

• 1 other identifier: H-46332
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This is an exploratory randomized controlled trial study to test feasibility, acceptability, and proof of concept efficacy of Continuous Diffusion of Oxygen (CDO) adjunct therapy for decreasing healing time and reducing tissue necrosis post breast reconstruction. The investigator will assess the benefit of this novel adjunct therapy on successful closure, tissue oxygenation, scar appearance, and patients centered outcomes including perception of benefit, pain, sleep quality, and quality of life. Eligible subjects will be randomly (ratio 1:1) assigned to either intervention group (IG) or control group (CG) and will be followed for four weeks. Both groups will receive standard of care for wound treatment. IG will also receive CDO adjunct therapy using a novel dressing, which facilitates continuously supplies oxygen to the wound inside the wound dressing using a portable device named TransCu O2. The study device TransCu O2® is a Class II medical device which has US Food and Drug Administration (FDA) 510(k) clearance, CE-Mark approval and a Health Canada license for the treatment of wounds. Outcomes will be assessed on weekly-basis up to 4 weeks.

Conditions

Surgical Wound; Breast Surgery; Mammoplasty; Incision Wound

Keywords

Infection; Dehiscense; Tissue infection; Surgical Revision; Scar tissue; Wound Closure

Outcome Measures

Primary Outcomes (2)

• Wound Size at 4 Weeks

  Wound size will be traced and quantified using a wound imaging system (Snapshot, Kent Imaging)

  4 weeks

• Incidence of Wound Complication at 4 Weeks

  Complication is described as infection, dehiscence, and/or necrotic tissue

  4 weeks

Secondary Outcomes (4)

• Presence of Scar Tissue

  4 weeks

• Change in DeoxyHB From Baseline to 4 Weeks

  Baseline to 4 weeks

• Self-reported Pain at Week 4

  At 4 weeks

• Change in Tissue Oxygen Saturation (SatO2) From Baseline to 4 Weeks

  Baseline to 4 weeks

Study Arms (3)

Direct Continuous Diffusion of Oxygen (dCDO)

ACTIVE COMPARATOR

One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Tegaderm adhesive.

Device: Transcu O2®; Other: Tegaderm

Control

NO INTERVENTION

One of the participant's breasts will receive a standard-of-care at the surgical site and will be followed for 4 weeks.

Silicon Continuous Diffusion of Oxygen (sCDO)

ACTIVE COMPARATOR

One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Silagen adhesive.

Device: Transcu O2®; Other: Silagen

Interventions

Transcu O2® DEVICE

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

Direct Continuous Diffusion of Oxygen (dCDO); Silicon Continuous Diffusion of Oxygen (sCDO)

Tegaderm OTHER

A 10 cm × 12 cm Tegaderm TM Film adhesive (3M Healthcare, Minnesota).

Direct Continuous Diffusion of Oxygen (dCDO)

Silagen OTHER

A 10 cm × 12 cm silicon sheet (Silagen, New Medical Technology, Inc, Illinois).

Silicon Continuous Diffusion of Oxygen (sCDO)

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 Continuous Diffusion of Oxygen (CDO) system (if assigned to the intervention group) and applicable dressing changes

You may not qualify if:

• Active Drug/alcohol abuse (or history of drug/alcohol abuse in last 1 month)
• Dementia or severely impaired cognitive function
• 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; Infections; Cicatrix

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Surgeries were performed on both breasts, with the intervention (either dCDO or sCDO) randomized to either the left or right breast, while the contralateral side served as the control. This design included 10 participants receiving dCDO and 10 receiving sCDO, with the contralateral breast of all 20 participants serving as the control. Unfortunately, ClinicalTrials.gov automatically calculates the total number of participants as double the actual count in this case.

Results Point of Contact

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

najafi.bijan@gmail.com

7137987536

Study Officials

• Bijan Najafi

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

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

Model Details: Each participant will act as their own control in this model. One of the participant's breasts will receive the intervention dressing while the other intervention breast will receive the standard of care.

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 13, 2020
• Study Start: June 1, 2021
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2025-01

Locations

US (1)