N/A
N=33
EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds
Surgical Wound · Diabetes · Amputation Wound · Incision Wound · Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT03960463 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants With Unfavorable Wound Healing Outcomes at 4 Weeks — 8; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcu O2® (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Unfavorable Wound Healing Outcomes at 4 Weeks |
8; 7 | — |
| SECONDARY Length of Wound |
4.78; 4.28; 3.57; 7.28 | — |
| SECONDARY Change in Skin Perfusion at Baseline and 4 Weeks |
62.2; 72.3; 63.1; 63.2 | — |
| SECONDARY Change in Percentage of Tissue Oxygen Saturation From Baseline to 4 Weeks |
50; 56; 50.6; 50 | — |
| SECONDARY Self-reported Pain at Week 4 |
2.09; 2.25 | — |
| SECONDARY Reintervention |
2; 2 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03960463). 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.