RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-19

Study Completion Date

2020-01-13

Brief Summary

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To evaluate whether the time to complete closure is superior for RECELL-treated split-thickness donor sites, compared with Control (standardized dressings only). The mean time for donor site healing will be compared between treatments.

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Detailed Description

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Conditions

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Skin; Deformity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each subject serves as their own control.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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RECELL® Autologous Cell Harvesting Device

RECELL + Telfa™ Clear and Xeroform™ dressings

Group Type EXPERIMENTAL

RECELL® Autologous Cell Harvesting Device

Intervention Type DEVICE

Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings

Telfa™ Clear and Xeroform™ dressings

Group Type ACTIVE_COMPARATOR

Telfa™ Clear and Xeroform™ dressings

Intervention Type OTHER

Telfa™ Clear and Xeroform™ dressings

Interventions

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RECELL® Autologous Cell Harvesting Device

Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings

Intervention Type DEVICE

Telfa™ Clear and Xeroform™ dressings

Intervention Type OTHER

Other Intervention Names

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RES (Regenerative Epidermal Suspension) Control

Eligibility Criteria

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Inclusion Criteria

1. Male or female patients aged 1 through 16 years (inclusive) with a skin defect for which autografting is indicated.
2. The area of total injury or planned defect (excluding donor sites) is 5% to 25% Total Body Surface Area (TBSA), inclusive.
3. Two discrete donor sites of similar size (± 25%) can be created in a similar non-articulating location (excluding the scalp) with each donor site representing a minimum of 1% TBSA.
4. The patient and family member/parent/guardian are able to complete all follow-up evaluations required by the study protocol.
5. In the opinion of the Investigator, the patient and/or parent/guardian must be able to:

1. Understand the full nature and purpose of the study, including possible risks and adverse events, and
2. Provide informed consent/assent as appropriate for study participation.
6. The patient and/or parent/guardian agrees to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary and comply with all compulsory study procedures.
7. The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
8. The patient and/or parent/guardian can read and understand instructions and give informed, voluntary, written consent.
9. Life expectancy greater than 52 weeks.

Exclusion Criteria

1. Prior autograft harvest at planned study donor sites.
2. Patients with sepsis or hemodynamic instability.
3. The patient has an infection under active management or other dermatologic condition at the planned donor sites or treatment areas.
4. Patient (of reasonable age) or parent/guardian is unable to follow the protocol requirements.
5. The patient has other concurrent conditions that in the opinion of the Investigator may compromise patient safety or study objectives.
6. Patients with a known hypersensitivity to trypsin or compound sodium lactate for irrigation.
7. In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
8. Enrollment in a concurrent study in which the study treatment may confound the endpoints of this study.

Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No