Trial · NCT07888166
Autologous Skin Cell Suspension (RECELL®) for Accelerated Healing of Split-Thickness Skin Graft Donor Sites: A Randomized, Intra-Patient (Split-Site) Controlled Trial
NCT07888166, Not applicable, Not yet recruiting, University of California, Davis
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Autologous Skin Cell Suspension (RECELL®) for Accelerated Healing of Split-Thickness Skin Graft Donor Sites: A Randomized, Intra-Patient (Split-Site) Controlled Trial. Trials, record NCT07888166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07888166
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Autologous Skin Cell Suspension (RECELL®) for Accelerated Healing of Split-Thickness Skin Graft Donor Sites: A Randomized, Intra-Patient (Split-Site) Controlled Trial
- NCT number
- NCT07888166
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 50 participants, estimated
- Lead sponsor
- University of California, Davis
- Conditions
- Skin Graft Donor Site, Wound Healing, Split-Thickness Skin Graft
- Interventions
- RECELL® Autologous Cell Harvesting Device, Standard Transparent Film Dressing
- First posted
- 2026-10-22
- Last updated
- 2026-10-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Complete Re-Epithelialization | 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. |
| Secondary | Patient and Observer Scar Assessment Scale 2.0 (POSAS 2.0) | At 3, 6, and 12 months post-surgery | 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. |
| Secondary | Vancouver Scar Scale (VSS) | At 3, 6, and 12 months post-surgery | 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. |
| Secondary | Complication Rate by Donor-Site Half | Through 12 months post-surgery | 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. |
| Secondary | Patient-Reported Pain and Itch (Visual Analog Scale) | At each early postoperative visit from postoperative day 5 until both halves reach complete re-epithelialization, up to approximately 21 days | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07888166
GET https://conductscience.org/api/trials/v1/NCT07888166/registered