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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 - 12 months for study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 - 12 months for study
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.
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Who is running the clinical trial?
Joshua ChooLead Sponsor
Integra LifeSciences CorporationIndustry Sponsor
84 Previous Clinical Trials
9,470 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition called osteomyelitis or osteoradionecrosis, or your bones don't have enough strength to support the implant.You have a medical history that could slow down the healing process of wounds or injuries, such as kidney disease or taking medicines that weaken your immune system.You are taking or planning to take medication that may slow down or negatively affect the healing of wounds.You are expected to have a defect in your skull that goes beyond the outer layer due to surgery to remove a tumor or damaged tissue.You are allergic to bovine collagen or chondroitin.You have received radiation treatment in the past.You have visible signs of an infected wound.
Research Study Groups:
This trial has the following groups:- Group 1: Single-arm prospective
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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