Recruiting

Integra

Sponsor:

Joshua Choo

Code:

NCT05311124

Conditions

Wound Care

Pressure Ulcer

Venous Ulcer

Surgical Wound

Trauma Wounds

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Integra Dermal Regeneration template (IDRT)

Study Details

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.

Conditions

Wound Care

Pressure Ulcer

Venous Ulcer

Surgical Wound

Trauma Wounds

Study ID

NCT05311124

Start date

Aug 1, 2022

Status verified date

Oct, 2022

Completion date

Oct 1, 2023

Anticipated

Primary completion date

Jun 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single-arm prospective

Single-arm prospective pilot study. All patients receive Integra dermal regeneration template (IDRT) that sign an inform consent.

Interventions

Integra 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.

Primary outcome measure

  • Time to complete closure [ Time Frame: 10 - 12 months for study ]
  • Percentage of subjects with complete closure of defect [ Time Frame: 10 - 12 months for study ]

Central Contacts and Locations

Central contacts

Locations

University of Louisville School of Medicine Division of Plastic Surgery

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Principal Investigator:

Joshua H. Choo, MD

More Information

Sponsor

Joshua Choo

Last update posted

Oct 18, 2022

Last verified

Oct, 2022

Keywords

  • Interga Dermal Regeneration Template (IDRT), Bare Calvarium, scalp wounds, skin graft

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Joshua Choo on 2022-10-18.