N/A N=46 Randomized Supportive Care

Continuous Diffusion of Oxygen Treatment for Incision Wounds

Surgical Wound · Breast Surgery · Mammoplasty · Incision Wound

Bottom Line

View on ClinicalTrials.gov: NCT04307355 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Wound Size at 4 Weeks — 1.5; 2.75; 0.15 cm^2

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Transcu O2® (Device); Tegaderm (Other); Silagen (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Baylor College of Medicine
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Wound Size at 4 Weeks	1.5; 2.75; 0.15	—
PRIMARY Incidence of Wound Complication at 4 Weeks	1; 3; 0	—
SECONDARY Presence of Scar Tissue	0; 0; 0	—
SECONDARY Change in DeoxyHB From Baseline to 4 Weeks	83.89; 136.07; 46.53	—
SECONDARY Self-reported Pain at Week 4	2.3; 3.9	—
SECONDARY Change in Tissue Oxygen Saturation (SatO2) From Baseline to 4 Weeks	-33.57; -23.30; 13.76	—

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.

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04307355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.