Trial reportThe Journal of trauma2009
Phase I/II clinical evaluation of StrataGraft: a consistent, pathogen-free human skin substitute.
Trial report in The Journal of trauma, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00618839 (Open-Label, Controlled, Randomized, Comparative, Dose Escalation Study Of The Safety, Human Immunology, And Efficacy Of StrataGraft™ Skin Tissue), which is not on this map. Cited by 34 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Open-Label, Controlled, Randomized, Comparative, Dose Escalation Study Of The Safety, Human Immunology, And Efficacy Of StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects In Patients Undergoing Sequential Skin Reconstruction Procedures
Who cites it
34 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Advancements in cell-based therapies for thermal burn wounds: a comprehensive systematic review of clinical trials outcomes.Stem cell research & therapy · 2024Pooled it
- StrataGraft skin substitute is well-tolerated and is not acutely immunogenic in patients with traumatic wounds: results from a prospective, randomized, controlled dose escalation trial.Annals of surgery · 2011Trial
- Dermal Templates Support Epidermal Regeneration and Maturation Regardless of Cell Donor Age.Tissue engineering. Part A · 2026Article
- Harnessing the Therapeutic Potential of Extracellular Vesicles for Oral Wound Healing.Bioengineering (Basel, Switzerland) · 2026Review
- Unveiling aging heterogeneities in human dermal fibroblasts via nanosensor chemical cytometry.Nature communications · 2025Article
- Strategies for the vascular patterning of engineered tissues for organ repair.Nature biomedical engineering · 2025Review
- Cell Immortality:Life (Basel, Switzerland) · 2024Review
- Ideal Living Skin Equivalents, From Old Technologies and Models to Advanced Ones: The Prospects for an Integrated Approach.BioMed research international · 2024Review
- Living Skin Substitute Tissue-Is a Replacement for the Autograft Possible?European burn journal · 2023Article
- Three-Dimensional Cell Cultures: The Bridge between In Vitro and In Vivo Models.International journal of molecular sciences · 2023Review
- Polymeric biomaterials for wound healing.Frontiers in bioengineering and biotechnology · 2023Review
- Decellularized Tissues for Wound Healing: Towards Closing the Gap Between Scaffold Design and Effective Extracellular Matrix Remodeling.Frontiers in bioengineering and biotechnology · 2022Review
- Indeterminate-Depth Burn Injury-Exploring the Uncertainty.The Journal of surgical research · 2020Review
- Isolation and Characterization of a Human Fetal Mesenchymal Stem Cell Population: Exploring the Potential for Cell Banking in Wound Healing Therapies.Cell transplantation · 2019Article
- Tissue engineering of skin and regenerative medicine for wound care.Burns & trauma · 2018Review
- Pediatric Thermal Burns and Treatment: A Review of Progress and Future Prospects.Medicines (Basel, Switzerland) · 2017Review
- Advances in Skin Regeneration Using Tissue Engineering.International journal of molecular sciences · 2017Review
- Autologous Bone Marrow Aspirate Therapy for Skin Tissue Engineering and Tissue Regeneration.Advances in wound care · 2017Article
- Advances of Stem Cell Therapeutics in Cutaneous Wound Healing and Regeneration.Mediators of inflammation · 2017Review
- Cellular Therapies in Trauma and Critical Care Medicine: Forging New Frontiers.Shock (Augusta, Ga.) · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
backgroundLarge wounds often require temporary allograft placement to optimize the wound bed and prevent infection until permanent closure is feasible. We developed and clinically tested a second-generation living human skin substitute (StrataGraft). StrataGraft provides both a dermis and a fully-stratified, biologically-functional epidermis generated from a pathogen-free, long-lived human keratinocyte progenitor cell line, Neonatal Immortalized KeratinocyteS (NIKS).
methodsHistology, electron microscopy, quantitative polymerase chain reaction, and bacterial growth in vitro were used to analyze human skin substitutes generated from primary human keratinocytes or NIKS cells. A phase I/II, National Institute of Health-funded, randomized, safety, and dose escalation trial was performed to assess autograft take in 15 patients 2 weeks after coverage with StrataGraft skin substitute or cryopreserved cadaver allograft.
resultsStrataGraft skin substitute exhibited a fully stratified epidermis with multilamellar lipid sheets and barrier function as well as robust human beta defensin-3 mRNA levels. Analysis of the primary endpoint in the clinical study revealed no differences in autograft take between wound sites pretreated with StrataGraft skin substitute or cadaver allograft. No StrataGraft-related adverse events or serious adverse events were observed.
conclusionsThe major finding of this phase I/II clinical study is that performance of StrataGraft skin substitute was comparable to cadaver allograft for the temporary management of complex skin defects. StrataGraft skin substitute may also eliminate the risk for disease transmission associated with allograft tissue and offer additional protection to the wound bed through inherent antimicrobial properties. StrataGraft is a pathogen-free human skin substitute that is ideal for the management of severe skin wounds before autografting.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.