Plastic and Reconstructive Surgery: Clinical Studies Open For Enrollment
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Eligibility
- 18 Years to 85 Years (Adult, Older Adult)
- Stage 2, 3, or 4 Pressure Injuries;
- Wound exudate is mild to moderate;
- No clinically active wound infection (clinical diagnosis);
- Able and willing to provide written (not proxy) informed consent;
- Clinically stable, as determined by assessment of medical history, vital signs, physical examination, and laboratory testing prior to enrollment.
- Exclusion criteria:
- Known allergy or hypersensitivity to TPD or its components;
- Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1;
- Heavily exudative wounds;
- Wound infection as defined as the presence of a least two of the following: local swelling or in duration, erythema >0.5cm around the ulcer in any direction, local tenderness or pain local warmth and purulent discharge;
- Poorly controlled diabetes with HgbA1C >12 (as documented in the last 3 months);
- Body Mass Index (BMI) >45 kg/m2;
- Venous stasis disease or lymphedema in the affected limb (if wound is located on the limb);
- Moderate to severe chronic limb ischemia Ankle Brachial Index (ABI) <0.7 on the affected limb, if wound is located on the limb);
- Received immunosuppression or biologics in the last six weeks and/or is expected to receive either at any point during the study;
- Selected concurrent treatments (e.g., hyperbaric oxygen, topical oxygen therapy, electrical stimulation, ultrasound, cellular or acellular skin substitutes) during study period that may impact study outcomes;
- Wounds with necrosis unable to undergo prior definitive debridement;
- Fistulas;
- Active gangrene;
- Untreated HIV
Enrollment Status: Open to enrollment
Study Information
ClinicalTrials.gov | NCT05496296
Principal Investigator
Helen Perakis, MD
Contact for Study Screening
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Eligibility
- Male or Female, Age > 21
- Has at least one target wound treated with a Kerecis device according to physician medical judgement within one calendar month prior to the registry enrollment date.
Enrollment Status: Open to enrollment
Study Information
ClinicalTrials.gov | NCT06384183
Principal Investigator
Helen Perakis, MD
Contact for Study Screening