Status:
UNKNOWN
Direct Application of Integra Bilayer Matrices on Bare Calvarium Without Preliminary Burring
Lead Sponsor:
Joshua Choo
Collaborating Sponsors:
Integra LifeSciences Corporation
Conditions:
Wound Care
Pressure Ulcer
Eligibility:
All Genders
55-100 years
Phase:
NA
Brief Summary
This study is to determine if large, full thickness scalp wounds with exposed calvarium resulting from acutely created extirpative defects can be reliably and durably resurfaced with IDRT without burr...
Detailed Description
Large full thickness scalp wounds often present a reconstructive challenge, as the size of the defect and the presence of denuded bone often preclude local flap options and skin grafting as methods of...
Eligibility Criteria
Inclusion
- Any full-thickness scalp wound extending to the cranium, devoid of pericranium that is:
- greater than or equal to 2 cm and/or is deemed by the treating physician not to be amenable to closure by simple means, primary closure or local flap.
- occurring in as elder patient \> 55 years old with co-morbid conditions that constitute and anesthetic risk (ASA) \>=3 that demonstrates punctate bleeding from healthy appearing cortical bone following debridement/extirpation
Exclusion
- hypersensitivity of bovine collagen and/or chondroitin
- previous treatment under same protocol
- current or planned treatment/medication know to interfere with the rate and quality of wound healing.
- suspected signs of wound infection
- suspected/known diagnosis of osteomyelitis, osteoradionecrosis, or non-availability of cortical bone
- anticipated defect following debridement or tumor extirpation extending past the outer cortical layer or cranium
- history of radiation to the field
- history of other conditions/illness compromising the wound healing process (ESRD, immunosuppression),
- absence of punctate cortical bleeding
- prior surgeries that would be expected to impair wound healing or vascularity of the underlying bone(e.g. history of craniectomy/bone flap, history of scalp flap/VP shunt.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05311124
Start Date
August 1 2022
End Date
October 1 2023
Last Update
October 18 2022
Active Locations (1)
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1
University of Louisville School of Medicine Division of Plastic Surgery
Louisville, Kentucky, United States, 40202