Draining Wound, Pressure Ulcer, Surgical Wound, Trauma Wounds, Venous Ulcer, Wound Care
Conditions
Keywords
Interga Dermal Regeneration Template (IDRT), Bare Calvarium, scalp wounds, skin graft
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 burring or fenestration as a preliminary step, regardless of the size of the calvarial defect.
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 coverage. Integra dermal regeneration template (IDRT) has shown great utility in these types of wounds due to its ability to take in wounds with diminished vascularity, but the limits of this ability have not been determined. When used for full thickness scalp defects with exposed calvarium, for example, the accepted practice is that burring of the outer table to gain access to the vascularized diploic space is a necessary prerequisite step, although this is not always possible or desirable. The clinical question being investigated is whether healthy calvarium is sufficient for durable IDRT and subsequent skin graft take in wounds with a large surface area of denuded calvarium.
Interventions
DEVICEIntegra Dermal Regeneration template (IDRT)
Integra Dermal Regeneration Template is a two-layer skin regeneration system. The outer layer is made of a thin silicone film that acts as your skin's epidermis. It protects the wound from infection and controls both heat and moisture loss. The inner layer is constructed of a complex matrix of cross-linked fibers. This porous material acts as a scaffold for regenerating dermal skin cells, which enables the re-growth of a functional dermal layer of skin. Once dermal skin has regenerated, the silicone outer layer is removed and replaced with a thin epidermal skin graft.
Sponsors
Integra LifeSciences Corporation
Joshua Choo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
The study design is a single-arm prospective pilot study with all patient receiving the IDRT wound care device.
Intervention model description
The study will be a single-arm prospective pilot study. Target of 10 enrolled patients at one study site under Joshua Choo, MD. Enrollment duration is 10 months - 1 year. Patients will have follow-up for 6 months per each patient.
Eligibility
Sex/Gender
ALL
Age
55 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete closure | 10 - 12 months for study | Time to complete closure (in days), as assessed by full re-epithelialization |
| Percentage of subjects with complete closure of defect | 10 - 12 months for study | Percentage of subjects with complete closure of defect |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent overall skin graft take | Follow-up of each patient is 6/months. | Percentage of overall skin graft take across all wounds as assessed by computerized planimetry (measured at 3 months) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Skin graft stability | Within a 6/month follow-up period | Skin graft stability as assessed by percentage skin graft take (measured at 6 months) |
| Histologic appearance of wounds treated with Integra immediately prior to skin graft | During study follow-up of 6/months | 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. |
| Assessment of neodermis formation | During study follow-up of 6/months. | 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. |
Countries
United States
Contacts
Primary ContactJoshua H. Choo, MD
Backup ContactBradon J. Wilhelmi, MD
Outcome results
None listed