Oncological wounds (e.g. radiation burns, cancerous wounds and surgical wounds once the cancerous tissue has been removed), traumatic wounds (e.g. abrasions and lacerations), cavity wounds (such as abdominal or thoracic) and wounds created from skin donor sites Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Patients will be seen and evaluated by a clinician to determine if their wound is appropriate to be treated with the KerraCel™ dressing. If yes, the clinician will make general observations of the wou
Sponsors
KCI (United States)
Eligibility
Sex/Gender
All
Age
22 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 18/03/2022: 1. Subjects who have been diagnosed with an oncological wound (e.g. radiation burns, cancerous wounds, and surgical wounds once the cancerous tissue has been removed), or traumatic wound (e.g. abrasions and lacerations), or cavity wound (wounds in a cavity) or skin donor site 2. Must be able to provide informed consent 3. Only one wound may be treated per subject for the study 4. Aged =22 years _____ Previous inclusion criteria: 1. Subjects who have been diagnosed with an oncological wound (e.g. radiation burns, cancerous wounds, and surgical wounds once the cancerous issue has been removed) or traumatic (e.g. abrasions and lacerations) wound. 2. Must be able to provide informed consent. 3. Only one wound may be treated per subject for the study. 4. Age =22 years.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 18/03/2022: 1. Has a known allergy to the dressing material 2. Has a wound that has uncontrolled heavy bleeding 3. Wound or burn larger than 20 cm in any direction 4. Pregnant or breastfeeding _____ Previous exclusion criteria: 1. Has a wound that requires packing of a body cavity with the KerraCel™ dressing, per the manufacturer’s instructions for use. 2. Has a wound that has not achieved hemostasis, per the manufacturer’s instructions for use. 3. Wound or burn larger than 20cm in any direction. 4. Pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-related adverse events measured using patient records up to the final visit (~21-28 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound healing and wound bed preparation by visual inspection of at baseline, ~day 7, 14, 21-28: 1. Decrease in wound size (volume, area, or depth) 2. Increase in % of wound granulation tissue 3. Wound moisture evaluation defined as wound exudate levels indicated as optimal 4. Decrease in % of nonviable tissue | — |
Countries
England, United Kingdom
Contacts
Public ContactLawrie Rogerson-Wynne
Outcome results
None listed