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Dermal Regeneration Template

Integra Dermal Regeneration template (IDRT) for Surgical Wound

N/A
Recruiting
Led By Joshua H Choo, MD
Research Sponsored by Joshua Choo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 - 12 months for study
Awards & highlights

Study Summary

This trial will test if large scalp wounds with bone exposure can be treated without extra steps, regardless of the size of the bone exposure.

Eligible Conditions
  • Surgical Wound
  • Pressure Sore
  • Wound Care
  • Venous Ulcers
  • Trauma Wound
  • Draining Wounds

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 - 12 months for study
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 - 12 months for study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of subjects with complete closure of defect
Time to complete closure
Secondary outcome measures
Percent overall skin graft take
Other outcome measures
Assessment of neodermis formation
Histologic appearance of wounds treated with Integra immediately prior to skin graft
Skin graft stability

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single-arm prospectiveExperimental Treatment1 Intervention
Single-arm prospective pilot study. All patients receive Integra dermal regeneration template (IDRT) that sign an inform consent.

Find a Location

Who is running the clinical trial?

Joshua ChooLead Sponsor
Integra LifeSciences CorporationIndustry Sponsor
84 Previous Clinical Trials
9,479 Total Patients Enrolled
3 Trials studying Surgical Wound
449 Patients Enrolled for Surgical Wound
Joshua H Choo, MDPrincipal InvestigatorUniversity of Louisville School of Medicine Division of Plastic Surgery

Media Library

Integra Dermal Regeneration Template (IDRT) (Dermal Regeneration Template) Clinical Trial Eligibility Overview. Trial Name: NCT05311124 — N/A
Surgical Wound Research Study Groups: Single-arm prospective
Surgical Wound Clinical Trial 2023: Integra Dermal Regeneration Template (IDRT) Highlights & Side Effects. Trial Name: NCT05311124 — N/A
Integra Dermal Regeneration Template (IDRT) (Dermal Regeneration Template) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05311124 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are persons of any age eligible for this research program?

"Patients between the ages of 55 and 100 are eligible to enroll in this trial. There are 179 studies available for those under 18, while 950 have been made accessible to individuals over 65."

Answered by AI

Are there any enrollment spots available for this clinical experiment?

"According to the details listed on clinicaltrials.gov, this research is presently seeking participants. It was initially shared on August 1st 2022 and recently updated October 17th of the same year."

Answered by AI

What is the patient sample size for this research endeavor?

"That is correct. According to the clinicaltrials.gov website, this medical experiment commenced on August 1st 2022 and has since been updated as recently as October 17th 2022; thus it is actively enrolling participants with only 10 needed from a single location."

Answered by AI

What type of participants is best suited for this trial?

"This research requires 10 individuals aged between 55-100 who currently possess a surgical wound. To be considered, the lesion must exceed 2 cm in size or not be treatable through simple closure or local flap methods and occur within an elderly patient with co-morbidities that constitute anaesthetic risk (ASA) >=3 and demonstrates punctate bleeding from healthy cortical bone following debridement/extirpation."

Answered by AI
Recent research and studies
~4 spots leftby Apr 2025