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Incision Wound clinical trials

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NCT ID: NCT04307355 Recruiting - Surgical Wound Clinical Trials

Continuous Diffusion of Oxygen Treatment for Incision Wounds

Start date: June 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT03960463 Recruiting - Breast Cancer Clinical Trials

EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds

Start date: May 18, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

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.