Pressure Ulcer Clinical Trial
Official title:
Direct Application of Integra Bilayer Matrices on Bare Calvarium Without Preliminary Burring: A Clinical and Histologic Study of Efficacy
NCT number | NCT05311124 |
Other study ID # | 21.0937 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2022 |
Est. completion date | October 1, 2023 |
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 burring or fenestration as a preliminary step, regardless of the size of the calvarial defect.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | October 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 100 Years |
Eligibility | Inclusion Criteria: Any full-thickness scalp wound extending to the cranium, devoid of pericranium that is: 1. 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. 2. 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 Criteria: 1. hypersensitivity of bovine collagen and/or chondroitin 2. previous treatment under same protocol 3. current or planned treatment/medication know to interfere with the rate and quality of wound healing. 4. suspected signs of wound infection 5. suspected/known diagnosis of osteomyelitis, osteoradionecrosis, or non-availability of cortical bone 6. anticipated defect following debridement or tumor extirpation extending past the outer cortical layer or cranium 7. history of radiation to the field 8. history of other conditions/illness compromising the wound healing process (ESRD, immunosuppression), 9. absence of punctate cortical bleeding 10. 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Louisville School of Medicine Division of Plastic Surgery | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Joshua Choo | Integra LifeSciences Corporation |
United States,
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* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Skin graft stability | Skin graft stability as assessed by percentage skin graft take (measured at 6 months) | Within a 6/month follow-up period | |
Other | Histologic appearance of wounds treated with Integra immediately prior to skin graft | Comparison of vascular ingrowth (measured by number of CD31 staining cells/hpf) and fibroblast infiltration (measured by density of anti-vimentin staining/hpf) at the periphery and center of provisional matrix immediately prior to skin graft in each reconstructed wound. | During study follow-up of 6/months | |
Other | Assessment of neodermis formation | Qualitative histologic analysis of tissue samples for presence of recognizable epidermis, dermis, rete-ridges and collagen organization resembling normal skin as assessed by independent pathologist's review at center and periphery of final reconstruction. | During study follow-up of 6/months. | |
Primary | Time to complete closure | Time to complete closure (in days), as assessed by full re-epithelialization | 10 - 12 months for study | |
Primary | Percentage of subjects with complete closure of defect | Percentage of subjects with complete closure of defect | 10 - 12 months for study | |
Secondary | Percent overall skin graft take | Percentage of overall skin graft take across all wounds as assessed by computerized planimetry (measured at 3 months) | Follow-up of each patient is 6/months. |
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