Skin Graft Donor SiteRECELL®-STSGNCT07888166
Autologous Skin Cell Suspension (RECELL®) for Accelerated Healing of Split-Thickness Skin Graft Donor Sites: A Randomized, Intra-Patient (Split-Site) Controlled Trial
A study testing RECELL® Autologous Cell Harvesting Device and Standard Transparent Film Dressing in people with Skin Graft Donor Site and Wound Healing, run by University of California, Davis at 1 site in United States.
Trial summary
This study evaluates whether applying RECELL® autologous skin cell suspension (ASCS) to one half of a split-thickness skin graft (STSG) donor site accelerates re-epithelialization and improves long-term scar quality compared with the untreated half of the same donor site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Graft Donor Site, Wound Healing, Split-Thickness Skin Graft
- What is being tested?
- RECELL® Autologous Cell Harvesting Device and Standard Transparent Film Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older at time of consent
- Scheduled to undergo split-thickness skin graft (STSG) harvest for any surgical indication (burn, trauma, oncologic reconstruction, chronic wound, or other)
- Able and willing to provide informed consent and comply with follow-up visits through 12 months
- Donor site anatomically able to be divided into two contiguous, comparable halves (e.g., anterolateral thigh)
- Willing to undergo standardized photographic documentation of the donor site
Who cannot join
- Donor site area insufficient to divide into two comparable, independently assessable halves (less than 20 cm² total)
- Known hypersensitivity to trypsin, or bovine or porcine-derived products used in RECELL® processing per device Instructions for Use
- Active infection, surgical incision, or trauma at the planned donor site
- Pregnancy
- Non-English-speaking patients
- Prisoners, cognitively impaired adults unable to consent, children, neonates, or other vulnerable populations as defined by the UC Davis IRB
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
Ian A. Powelson, MD, 916-453-2180, iapowelson@health.ucdavis.edu
About this study
This study evaluates whether applying RECELL® autologous skin cell suspension (ASCS) to one half of a split-thickness skin graft (STSG) donor site accelerates re-epithelialization and improves long-term scar quality compared with the untreated half of the same donor site. Using a prospective, randomized, intra-patient (split-site) controlled design, each participant's donor site is divided into two contiguous, comparable halves at the time of surgery; one half is randomized to receive RECELL® application plus standard transparent film dressing, while the other receives standard dressing alone. Each participant serves as their own control, eliminating inter-patient variability in healing. Participants are followed for 12 months with serial standardized digital photography, blinded outcome assessment, and validated scar-assessment instruments (POSAS 2.0, Vancouver Scar Scale).
Read the detailed description
Split-thickness skin graft (STSG) donor-site morbidity-defined as pain, prolonged healing, dyspigmentation, and hypertrophic scarring-remains a persistent source of patient dissatisfaction and, in a minority of cases, a site more symptomatic than the original wound. Standard donor-site management at UC Davis uses an absorptive/antimicrobial dressing (Telfa or Mepilex Ag) left undisturbed for approximately five days to support re-epithelialization from residual dermal appendages.
RECELL® is an FDA-approved point-of-care device (PMA BP170122) that processes a small split-thickness skin sample into a non-cultured ASCS containing keratinocytes, melanocytes, and fibroblasts, which is sprayed directly onto the wound bed to seed re-epithelialization. RECELL® is currently approved for acute thermal burns (2018), full-thickness skin defects from surgical excision or traumatic avulsion (2023), and repigmentation of stable vitiligo (2021). Its labeled indications do not include STSG donor sites specifically, which are partial-thickness, iatrogenic wounds.
A published randomized controlled trial (Hu et al., BJS 2017; n=106) found median time to complete re-epithelialization of 9.0 days (95% CI 8.3-9.7) with ASCS versus 13.0 days (95% CI 12.4-13.6) with control (p less than 0.001), with no difference in complication rates. A subsequent systematic review and meta-analysis confirmed a pooled reduction in healing time favoring the cell-suspension arm, with reduced pain scores; however, scar-scale and satisfaction outcomes did not differ significantly between groups.
This study extends that evidence base using the currently marketed RECELL® device, an intra-patient split-site design (which controls for inter-patient variability more efficiently than the parallel-group design used by Hu et al.), and adds long-term (12-month) aesthetic and complication follow-up, including hypertrophic scarring and keloid formation, which prior donor-site trials have not consistently powered for.
Study Design: At the time of STSG harvest, the donor site is divided into two contiguous, comparable halves (e.g., proximal/distal along the anterolateral thigh). Randomization via REDCap assigns which half receives RECELL®. Both halves are dressed with the same transparent polyurethane film dressing so that epithelialization can be assessed serially through the dressing without disturbing the wound bed. Due to the nature of RECELL® application, operating surgeons and the study coordinator cannot be blinded; however, subjects are not informed of their treatment allocation until after the 12-month visit, and outcome assessors evaluate cropped, coded photographs blinded to treatment assignment.
Follow-up visits occur every 2-3 days from POD 5 until both halves reach complete re-epithelialization, then at 4 weeks, 3 months, 6 months, and 12 months. Standardized digital photography, pain and itch VAS, POSAS 2.0, and Vancouver Scar Scale assessments are obtained at pre-specified intervals per the Schedule of Assessments. All data are stored in UC Davis REDCap. Four plastic surgery attendings at UC Davis Medical Center will enroll participants. Safety monitoring is performed by the PI, operating surgeons, blinded reviewers, a plastic surgery resident, a medical student, and a biostatistician, with reports submitted to the UC Davis IRB at periodic Continuing Reviews.
- Being tested
- RECELL® Autologous Cell Harvesting Device, Standard Transparent Film Dressing
- Keywords
- RECELL, Autologous Skin Cell Suspension, Split-Thickness Skin Graft, Donor Site, Re-epithelialization, Scar, Wound Healing
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECELL® Autologous Cell Harvesting DeviceDevice
RECELL® (FDA PMA BP170122) is a point-of-care device that processes a small split-thickness skin biopsy into a non-cultured autologous skin cell suspension (ASCS) containing keratinocytes, melanocytes, and fibroblasts. The suspension is sprayed directly onto the randomized donor-site half intraoperatively to seed re-epithelialization, followed by application of a transparent polyurethane film dressing. This application to STSG donor sites represents an off-label use of the device. The device is classified as non-significant risk and is exempt from the IDE requirement.
Standard Transparent Film DressingDevice
Standard institutional transparent polyurethane film dressing (Telfa or Mepilex Ag) applied to the control half of the STSG donor site immediately following graft harvest. This represents the current institutional standard of care for STSG donor-site management at UC Davis Medical Center. The dressing is left undisturbed for approximately five days and changed thereafter only per surgeon judgment or if compromised (soiled, leaking, or non-adherent).
| Study group | Role | What they receive |
|---|---|---|
| RECELL-Treated Donor-Site Half | Experimental | The randomly assigned half of the STSG donor site receives RECELL® autologous skin cell suspension (ASCS) application followed by standard transparent film dressing (Telfa or Mepilex Ag). RECELL® processing and application are performed by the operating surgeon per manufacturer Instructions for Use (IFU) in the operating room immediately following STSG harvest. A small additional skin sample (approximately postage-stamp sized per palm-sized treatment area) is obtained from within the existing donor-site footprint when anatomy permits, or from nearby if required. Receives: Device: RECELL® Autologous Cell Harvesting Device |
| Control Donor-Site Half | Active comparator | The other contiguous half of the same STSG donor site on the same subject receives standard transparent film dressing alone (Telfa or Mepilex Ag), which represents the current institutional standard of care for donor-site management at UC Davis Medical Center. No RECELL® application is made to this half. Both halves are covered with the same dressing type to allow blinded serial photographic assessment of epithelialization through the transparent dressing without disturbing the wound bed. Receives: Device: Standard Transparent Film Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Re-Epithelialization
Time to complete (100%) re-epithelialization of each donor-site half, defined as the absence of any exposed dermis on standardized digital photography. Assessed independently by two blinded reviewers not involved in the patient's clinical care. Photographs are cropped and coded so reviewers cannot infer treatment assignment from dressing appearance or clinical notes. Discrepancies between the two primary reviewers are adjudicated by a third blinded reviewer. Primary analysis uses a paired t-test or Wilcoxon signed-rank test if the distribution of paired differences is non-normal; a mixed-effects model with subject as a random effect and surgeon as a fixed or random covariate is used to formally test for surgeon-by-treatment interaction.
Measured: From day of surgery, assessed every 2-3 days beginning postoperative day 5, up to 21 days
Secondary outcomes (4)
Patient and Observer Scar Assessment Scale 2.0 (POSAS 2.0)
Comparison of long-term aesthetic outcome between the RECELL-treated and untreated donor-site halves using the Patient and Observer Scar Assessment Scale 2.0 (POSAS 2.0), including both patient and observer components. Scored from standardized photographs by assessors blinded to treatment allocation where feasible. Paired non-parametric tests are used for ordinal scale data.
Measured: At 3, 6, and 12 months post-surgery
Vancouver Scar Scale (VSS)
Comparison of scar quality between the RECELL-treated and untreated donor-site halves using the Vancouver Scar Scale (VSS), scored from standardized photographs by assessors blinded to treatment allocation. Paired non-parametric tests are used for ordinal scale data.
Measured: At 3, 6, and 12 months post-surgery
Complication Rate by Donor-Site Half
Incidence and characterization of complications compared between the RECELL-treated and untreated donor-site halves, including: hypertrophic scarring, keloid formation, wound breakdown or dehiscence, delayed healing (greater than 21 days to complete closure), surgical site infection, prolonged bleeding, and any hypersensitivity or local reaction attributable to RECELL processing reagents. Complication rates compared using McNemar's test for paired binary outcomes.
Measured: Through 12 months post-surgery
Patient-Reported Pain and Itch (Visual Analog Scale)
Patient-reported pain and itch scores using a visual analog scale (VAS) at each early postoperative visit, compared between the RECELL-treated and untreated donor-site halves. Assessed at postoperative day 5 and at every 2-3 day interval visit thereafter until both halves reach complete re-epithelialization.
Measured: At each early postoperative visit from postoperative day 5 until both halves reach complete re-epithelialization, up to approximately 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Skin Graft Donor SiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, randomized, intra-patient (split-donor-site) controlled trial. Each subject's STSG donor site is divided into two contiguous, comparable halves at the time of surgery. One half is randomized via REDCap to receive RECELL® autologous skin cell suspension plus standard transparent film dressing; the other half receives standard transparent film dressing alone. Each participant receives both interventions simultaneously on different halves of the same donor site and serves as their own control, eliminating inter-patient variability in wound healing.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian A. Powelson, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888166
- Sponsor's protocol ID
- 2472559
- Acronym
- RECELL®-STSG
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared. This is a single-site study with a small enrollment target, and the dataset is linked to direct identifiers on REDCap. Wound photographs also carry re-identification risk that cannot be fully removed from a dataset this small. Participant consent and the HIPAA authorization cover research use by the UC Davis study team only. Results will be reported in aggregate in peer-reviewed publications and on ClinicalTrials.gov.
Publications
Kahn SA, Carter JE, Wilde S, Chamberlain A, Walsh TP, Sparks JA. Autologous Skin Cell Suspension for Full-Thickness Skin Defect Reconstruction: Current Evidence and Health Economic Expectations. Adv Ther. 2024 Mar;41(3):891-900. doi: 10.1007/s12325-023-02777-7. Epub 2024 Jan 22.
PubMed 38253788Van den Bergh, B., Kruger, D., Kourie, J., Moeng, S. and C. Robson, M. (2018) A Prospective, Within-Patient Controlled Study to Compare the Ability of the Non Adherent Drawtex® Hydroconductive Dressing to a Transparent Polyurethane Film Dressing (Standard of Care) on the Healing of Split-Thickness Skin Graft Donor Sites*. Surgical Science, 9, 210-221. doi: 10.4236/ss.2018.97025.
US Food & Drug Administration. RECELL Autologous Cell Harvesting Device (PMA BP170122). https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/recell-autologous-cell-harvesting-device
Bairagi A, Griffin B, Banani T, McPhail SM, Kimble R, Tyack Z. A systematic review and meta-analysis of randomized trials evaluating the efficacy of autologous skin cell suspensions for re-epithelialization of acute partial thickness burn injuries and split-thickness skin graft donor sites. Burns. 2021 Sep;47(6):1225-1240. doi: 10.1016/j.burns.2021.04.005. Epub 2021 Apr 16.
PubMed 33941398Hu Z, Guo D, Liu P, Cao X, Li S, Zhu J, Tang B. Randomized clinical trial of autologous skin cell suspension for accelerating re-epithelialization of split-thickness donor sites. Br J Surg. 2017 Jun;104(7):836-842. doi: 10.1002/bjs.10508. Epub 2017 Apr 5.
PubMed 28379607
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Skin Cell Suspension (RECELL®) for Accelerated Healing of Split-Thickness Skin Graft Donor Sites: A Randomized, Intra-Patient (Split-Site) Controlled Trial
- ClinicalTrials.gov ID
- NCT07888166
- Acronym / sponsor ID
- RECELL®-STSG / 2472559
- Keywords
- RECELL, Autologous Skin Cell Suspension, Split-Thickness Skin Graft, Donor Site, Re-epithelialization, Scar, Wound Healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates whether applying RECELL® autologous skin cell suspension (ASCS) to one half of a split-thickness skin graft (STSG) donor site accelerates re-epithelialization and improves long-term scar quality compared with the untreated half of the same donor site. Using a prospective, randomized, intra-patient (split-site) controlled design, each participant's donor site is divided into two contiguous, comparable halves at the time of surgery; one half is randomized to receive RECELL® application plus standard transparent film dressing, while the other receives standard dressing alone. Each participant serves as their own control, eliminating inter-patient variability in healing. Participants are followed for 12 months with serial standardized digital photography, blinded outcome assessment, and validated scar-assessment instruments (POSAS 2.0, Vancouver Scar Scale).
Detailed description
Split-thickness skin graft (STSG) donor-site morbidity-defined as pain, prolonged healing, dyspigmentation, and hypertrophic scarring-remains a persistent source of patient dissatisfaction and, in a minority of cases, a site more symptomatic than the original wound. Standard donor-site management at UC Davis uses an absorptive/antimicrobial dressing (Telfa or Mepilex Ag) left undisturbed for approximately five days to support re-epithelialization from residual dermal appendages.
RECELL® is an FDA-approved point-of-care device (PMA BP170122) that processes a small split-thickness skin sample into a non-cultured ASCS containing keratinocytes, melanocytes, and fibroblasts, which is sprayed directly onto the wound bed to seed re-epithelialization. RECELL® is currently approved for acute thermal burns (2018), full-thickness skin defects from surgical excision or traumatic avulsion (2023), and repigmentation of stable vitiligo (2021). Its labeled indications do not include STSG donor sites specifically, which are partial-thickness, iatrogenic wounds.
A published randomized controlled trial (Hu et al., BJS 2017; n=106) found median time to complete re-epithelialization of 9.0 days (95% CI 8.3-9.7) with ASCS versus 13.0 days (95% CI 12.4-13.6) with control (p less than 0.001), with no difference in complication rates. A subsequent systematic review and meta-analysis confirmed a pooled reduction in healing time favoring the cell-suspension arm, with reduced pain scores; however, scar-scale and satisfaction outcomes did not differ significantly between groups.
This study extends that evidence base using the currently marketed RECELL® device, an intra-patient split-site design (which controls for inter-patient variability more efficiently than the parallel-group design used by Hu et al.), and adds long-term (12-month) aesthetic and complication follow-up, including hypertrophic scarring and keloid formation, which prior donor-site trials have not consistently powered for.
Study Design: At the time of STSG harvest, the donor site is divided into two contiguous, comparable halves (e.g., proximal/distal along the anterolateral thigh). Randomization via REDCap assigns which half receives RECELL®. Both halves are dressed with the same transparent polyurethane film dressing so that epithelialization can be assessed serially through the dressing without disturbing the wound bed. Due to the nature of RECELL® application, operating surgeons and the study coordinator cannot be blinded; however, subjects are not informed of their treatment allocation until after the 12-month visit, and outcome assessors evaluate cropped, coded photographs blinded to treatment assignment.
Follow-up visits occur every 2-3 days from POD 5 until both halves reach complete re-epithelialization, then at 4 weeks, 3 months, 6 months, and 12 months. Standardized digital photography, pain and itch VAS, POSAS 2.0, and Vancouver Scar Scale assessments are obtained at pre-specified intervals per the Schedule of Assessments. All data are stored in UC Davis REDCap. Four plastic surgery attendings at UC Davis Medical Center will enroll participants. Safety monitoring is performed by the PI, operating surgeons, blinded reviewers, a plastic surgery resident, a medical student, and a biostatistician, with reports submitted to the UC Davis IRB at periodic Continuing Reviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, intra-patient (split-donor-site) controlled trial. Each subject's STSG donor site is divided into two contiguous, comparable halves at the time of surgery. One half is randomized via REDCap to receive RECELL® autologous skin cell suspension plus standard transparent film dressing; the other half receives standard transparent film dressing alone. Each participant receives both interventions simultaneously on different halves of the same donor site and serves as their own control, eliminating inter-patient variability in wound healing.
| Arm | Type | Receives |
|---|---|---|
| RECELL-Treated Donor-Site Half | Experimental | Device: RECELL® Autologous Cell Harvesting DeviceThe randomly assigned half of the STSG donor site receives RECELL® autologous skin cell suspension (ASCS) application followed by standard transparent film dressing (Telfa or Mepilex Ag). RECELL® processing and application are performed by the operating surgeon per manufacturer Instructions for Use (IFU) in the operating room immediately following STSG harvest. A small additional skin sample (approximately postage-stamp sized per palm-sized treatment area) is obtained from within the existing donor-site footprint when anatomy permits, or from nearby if required. |
| Control Donor-Site Half | Active comparator | Device: Standard Transparent Film DressingThe other contiguous half of the same STSG donor site on the same subject receives standard transparent film dressing alone (Telfa or Mepilex Ag), which represents the current institutional standard of care for donor-site management at UC Davis Medical Center. No RECELL® application is made to this half. Both halves are covered with the same dressing type to allow blinded serial photographic assessment of epithelialization through the transparent dressing without disturbing the wound bed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older at time of consent
- Scheduled to undergo split-thickness skin graft (STSG) harvest for any surgical indication (burn, trauma, oncologic reconstruction, chronic wound, or other)
- Able and willing to provide informed consent and comply with follow-up visits through 12 months
- Donor site anatomically able to be divided into two contiguous, comparable halves (e.g., anterolateral thigh)
- Willing to undergo standardized photographic documentation of the donor site
Key exclusion criteria (6 listed)
- Donor site area insufficient to divide into two comparable, independently assessable halves (less than 20 cm² total)
- Known hypersensitivity to trypsin, or bovine or porcine-derived products used in RECELL® processing per device Instructions for Use
- Active infection, surgical incision, or trauma at the planned donor site
- Pregnancy
- Non-English-speaking patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RECELL® Autologous Cell Harvesting DeviceRECELL® (FDA PMA BP170122) is a point-of-care device that processes a small split-thickness skin biopsy into a non-cultured autologous skin cell suspension (ASCS) containing keratinocytes, melanocytes, and fibroblasts. The suspension is sprayed directly onto the randomized donor-site half intraoperatively to seed re-epithelialization, followed by application of a transparent polyurethane film dressing. This application to STSG donor sites represents an off-label use of the device. The device is classified as non-significant risk and is exempt from the IDE requirement. | Device | RECELL-Treated Donor-Site Half |
| Standard Transparent Film DressingStandard institutional transparent polyurethane film dressing (Telfa or Mepilex Ag) applied to the control half of the STSG donor site immediately following graft harvest. This represents the current institutional standard of care for STSG donor-site management at UC Davis Medical Center. The dressing is left undisturbed for approximately five days and changed thereafter only per surgeon judgment or if compromised (soiled, leaking, or non-adherent). | Device | Control Donor-Site Half |
Primary outcome
Time to Complete Re-Epithelialization
Time frame: From day of surgery, assessed every 2-3 days beginning postoperative day 5, up to 21 days
Time to complete (100%) re-epithelialization of each donor-site half, defined as the absence of any exposed dermis on standardized digital photography. Assessed independently by two blinded reviewers not involved in the patient's clinical care. Photographs are cropped and coded so reviewers cannot infer treatment assignment from dressing appearance or clinical notes. Discrepancies between the two primary reviewers are adjudicated by a third blinded reviewer. Primary analysis uses a paired t-test or Wilcoxon signed-rank test if the distribution of paired differences is non-normal; a mixed-effects model with subject as a random effect and surgeon as a fixed or random covariate is used to formally test for surgeon-by-treatment interaction.
4 secondary outcomes
Patient and Observer Scar Assessment Scale 2.0 (POSAS 2.0)
Time frame: At 3, 6, and 12 months post-surgery
Vancouver Scar Scale (VSS)
Time frame: At 3, 6, and 12 months post-surgery
Complication Rate by Donor-Site Half
Time frame: Through 12 months post-surgery
Patient-Reported Pain and Itch (Visual Analog Scale)
Time frame: At each early postoperative visit from postoperative day 5 until both halves reach complete re-epithelialization, up to approximately 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 38253788Kahn SA, Carter JE, Wilde S, Chamberlain A, Walsh TP, Sparks JA. Autologous Skin Cell Suspension for Full-Thickness Skin Defect Reconstruction: Current Evidence and Health Economic Expectations. Adv Ther. 2024 Mar;41(3):891-900. doi: 10.1007/s12325-023-02777-7. Epub 2024 Jan 22.
- BackgroundVan den Bergh, B., Kruger, D., Kourie, J., Moeng, S. and C. Robson, M. (2018) A Prospective, Within-Patient Controlled Study to Compare the Ability of the Non Adherent Drawtex® Hydroconductive Dressing to a Transparent Polyurethane Film Dressing (Standard of Care) on the Healing of Split-Thickness Skin Graft Donor Sites*. Surgical Science, 9, 210-221. doi: 10.4236/ss.2018.97025.
- BackgroundUS Food & Drug Administration. RECELL Autologous Cell Harvesting Device (PMA BP170122). https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/recell-autologous-cell-harvesting-device
- Background: PubMed 33941398Bairagi A, Griffin B, Banani T, McPhail SM, Kimble R, Tyack Z. A systematic review and meta-analysis of randomized trials evaluating the efficacy of autologous skin cell suspensions for re-epithelialization of acute partial thickness burn injuries and split-thickness skin graft donor sites. Burns. 2021 Sep;47(6):1225-1240. doi: 10.1016/j.burns.2021.04.005. Epub 2021 Apr 16.
- Background: PubMed 28379607Hu Z, Guo D, Liu P, Cao X, Li S, Zhu J, Tang B. Randomized clinical trial of autologous skin cell suspension for accelerating re-epithelialization of split-thickness donor sites. Br J Surg. 2017 Jun;104(7):836-842. doi: 10.1002/bjs.10508. Epub 2017 Apr 5.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. This is a single-site study with a small enrollment target, and the dataset is linked to direct identifiers on REDCap. Wound photographs also carry re-identification risk that cannot be fully removed from a dataset this small. Participant consent and the HIPAA authorization cover research use by the UC Davis study team only. Results will be reported in aggregate in peer-reviewed publications and on ClinicalTrials.gov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ian A. Powelson, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RECELL® Autologous Cell Harvesting Device and Standard Transparent Film Dressing in people with Skin Graft Donor Site and Wound Healing, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ian A. Powelson, MD (916-453-2180, iapowelson@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Complete Re-Epithelialization (time frame: From day of surgery, assessed every 2-3 days beginning postoperative day 5, up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07888166, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.