Autologous Regenerative Technology (ART) For Wound Healing

May 3, 2022 updated by: Geoffrey C. Gurtner, Stanford University
The purpose of the study is to provide a more effective method of harvesting skin with minimal or no pain, heal more rapidly with little scarring in an outpatient setting with the use of only local anesthesia.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Skin wounds sometimes are difficult to heal by primary closure and often require tissue substitution by autologous grafting requiring harvesting of donor skin. The latter may cause morbidities such as risk of infection, discoloration, pain, and scarring of both donor and recipient areas. Full-thickness stin grafts (FTSG) are created when the entire dermis and epidermis are harvested, These grafts are typically used for acute full-thickness wounds where the wound can sustain and nourish the graft and improved cosmesis is important. Split-thickness skin grafting (STSG) has been used to close large skin wounds, and it involves the harvesting of the epidermis and upper dermis from a donor site. It is generally the preferred grafting method for restoring the structural integrity of chronic wounds, as the wound bed may not have the ability to support a FTSG. Nevertheless, because deep dermal structures such as sweat glands and hair follicles are not harvested, the STSG is functionally abnormal. Before the grafting process takes place, STSGs are commonly meshed and enlarged, increasing the coverage area and allowing fluid drainage. However, the meshing process produces a "fish-net" appearance of the grafted skin. Other limitations include healing of the donor site, which often is delayed and leaves unappealing pigmentary changes and, at times, scar formation.

Currently, engineered "off the shelf" grafts such as cadaveric skin, xenografts, and artificial skin substitutes are being used in the management of chronic, difficult to heal wounds. Skin substitutes work by providing cells, growth factors, and other key elements that promote healing while preventing extracellular matrix degradation. However, these only offer transient wound coverage, and require secondary healing of the wound itself. Thus, autologous skin grafting continues to be necessary. Scar formation at the donor and grafted site remain most troublesome morbidities in autologous skin grafting. Scar tissue is stiff, dysfunctional, often painful, and tends to contract over time, producing skin irregularities.

In contrast, skin remodeling is a process that substitutes missing tissue while preserving tissue architecture. While scarring is triggered by large-scale tissue damage, remodeling is stimulated by microscopic tissue damage. This principle became clear when fractional photothermolysis (FP) was developed that is currently used for photoaged skin treatment and wound scars. In FP, laser microbeams are used to produce microscopic thermal injury per cm2 of skin surface, which causes very thin columns of tissue damage or ablation. It has been found that columns less than 500 µm in diameter heal promptly without scarring. FP involves full-thickness (i.e. complete epidermis and dermis) tissue injury in which the epidermis closes within 1 day, and the dermal damage is fixed in around 2 weeks, followed by tissue remodeling without scarring.

Because the experience with FP showed that millions of small, full-thickness columns of skin tissue can be removed without scarring, it was hypothesized that full-thickness microscopic skin tissue columns (MSTCs) could be harvested from healthy skin with insignificant donor site-morbidity and that these MSTCs could function as a graft to accelerate wound healing.

To explore this, a prototype device was developed that can harvest hundreds of full-thickness columns of skin tissue (500 micrometer diameter) using single-needle, fluid-assisted harvesting technology. The harvested MSTCs can subsequently be placed directly onto a wound to aid in healing.

With conventional full thickness grafts and split thickness grafts, the donor area requires sometimes a period of immobility, requiring attentive wound care and pain management. The ART may provide a more effective method of harvesting skin with minimal or no pain, healing rapidly with little scarring. This can take place in an outpatient setting, with the use of only local anesthesia.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Redwood City, California, United States, 94063
        • Stanford Advanced Wound Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any age ranging 18-90, any gender or ethnic background is a candidate.
  • Subjects with chronic wounds that have been present for at least 4 weeks

Exclusion Criteria:

  • Pregnant women.
  • Adults unable to consent.
  • Prisoners.
  • Subjects requiring concurrent systemic antimicrobials during the study period for any infection.
  • Subjects with leg lesions and clinically significant and unreconstructed peripheral arterial disease.
  • Subjects who are receiving immunosuppressive agents, radiation therapy, or cytotoxic agents.
  • Subjects who require treatment for a primary or metastatic malignancy (other than squamous or basal cell carcinoma of the skin).
  • Subjects with other conditions considered by the investigator to be reasons for disqualification that may jeopardize subject safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Skin Wound Patients
Patients will receive ART for wound healing and will be followed for 28 days to determine success of the procedure.
ART device with single-needle, fluid-assisted skin tissue harvesting technology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported pain at skin donor site at Day 7
Time Frame: Day 7
Pain will be assessed on an 11-point visual analogue scale (range 0 to 10, with 0 corresponding to no pain, and 10 corresponding to the worst pain imaginable)
Day 7
Patient-reported pain at skin donor site at Day 14
Time Frame: Day 14
Pain will be assessed on an 11-point visual analogue scale (range 0 to 10, with 0 corresponding to no pain, and 10 corresponding to the worst pain imaginable)
Day 14
Patient-reported pain at skin donor site at Day 21
Time Frame: Day 21
Pain will be assessed on an 11-point visual analogue scale (range 0 to 10, with 0 corresponding to no pain, and 10 corresponding to the worst pain imaginable)
Day 21
Patient-reported pain at skin donor site at Day 28
Time Frame: Day 28
Pain will be assessed on an 11-point visual analogue scale (range 0 to 10, with 0 corresponding to no pain, and 10 corresponding to the worst pain imaginable)
Day 28
Patient-reported tolerability of ART procedure
Time Frame: End of study (Day 28)
Tolerability will be assessed on an 10-point scale (range 1 to 10, with 1 corresponding to most tolerable, and 10 corresponding to least tolerable)
End of study (Day 28)
Physician-reported tolerability of ART procedure
Time Frame: End of study (Day 28)
Tolerability will be assessed on an 10-point scale (range 1 to 10, with 1 corresponding to most tolerable, and 10 corresponding to least tolerable)
End of study (Day 28)
Percent change in size of wound area as a measure of time to healing at Day 7
Time Frame: Day 7
Day 7
Percent change in size of wound area as a measure of time to healing at Day 14
Time Frame: Day 14
Day 14
Percent change in size of wound area as a measure of time to healing at Day 21
Time Frame: Day 21
Day 21
Percent change in size of wound area as a measure of time to healing at Day 28
Time Frame: Day 28
Day 28
Time to full epithelialization as a measure of quality of healing
Time Frame: Baseline to Day 28
Epithelialization is defined as growth of epithelium over the wound surface
Baseline to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

November 27, 2017

First Submitted That Met QC Criteria

December 7, 2017

First Posted (ACTUAL)

December 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 42628

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No current plan to share data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Wounds

Clinical Trials on Autologous Regenerative Technology (ART)

Search Similar Trials