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Multicenter postapproval clinical trial of Integra dermal regeneration template for burn treatment
Abstract
The safety and effectiveness of Integra® Dermal Regeneration Template was evaluated in a postapproval study involving 216 burn injury patients who were treated at 13 burn care facilities in the United States. The mean total body surface area burned was 36.5% (range, 1–95%). Integra® was applied to fresh, clean, surgically excised burn wounds. Within 2 to 3 weeks, the dermal layer regenerated, and a thin epidermal autograft was placed. The incidence of invasive infection at Integra®-treated sites was 3.1% (95% confidence interval, 2.0–4.5%) and that of superficial infection 13.2% (95% confidence interval, 11.0–15.7%). Mean take rate of Integra® was 76.2%; the median take rate was 95%. The mean take rate of epidermal autograft was 87.7%; the median take rate was 98%. This postapproval study further supports the conclusion that Integra® is a safe and effective treatment modality in the hands of properly trained clinicians under conditions of routine clinical use at burn centers.
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“Some published articles have already proved its efficacy and safety in third degree burns, scar reconstruction, acute and chronic wounds [17,18].”
From Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis (2017) · cites this paper as [18]
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Research works printed but not linked: 31
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Cited by
A clinical trial of Integra Template for diabetic foot ulcer treatment
Driver, V. R., Lavery, L. A., Reyzelman, A. M., Dutra, T. G., Dove, C. R., Kotsis, S. V., Kim, H. M., & Chung, K. C. (2015) · Wound Repair and Regeneration · doi:10.1111/wrr.12357 · Cited by 291
Guo, X., Mu, D., & Gao, F. (2017) · International Journal of Surgery · doi:10.1016/j.ijsu.2017.02.008 · Cited by 80
Extracellular matrix-inspired biomaterials for wound healing
Hosty, L., Heatherington, T., Quondamatteo, F., & Browne, S. (2024) · Molecular Biology Reports · doi:10.1007/s11033-024-09750-9 · Cited by 63
Capella-Monsonís, H., De Pieri, A., Peixoto, R., Korntner, S., & Zeugolis, D. I. (2020) · Stem Cell Research & Therapy · doi:10.1186/s13287-020-02021-x · Cited by 42
In vitro skin models to study epithelial regeneration from the hair follicle
Ojeh, N., Akgül, B., Tomic-Canic, M., Philpott, M., & Navsaria, H. (2017) · PLOS ONE · doi:10.1371/journal.pone.0174389 · Cited by 23
Metadata
- Authors
- Heimbach, D. M., Warden, G. D., Luterman, A., Jordan, M. H., Ozobia, N., Ryan, C. M., Voigt, D. W., Hickerson, W. L., Saffle, J. R., DeClement, F. A., Sheridan, R. L., & Dimick, A. R.
- Affiliations
- Department of Surgery, University of Washington, Seattle, Washington
- Shriners Burn Institute, Cincinnati, Ohio
- Department of Surgery, University of South Alabama, Mobile, Alabama
- Washington Hospital Center, Washington, DC
- Lions Burns Care Center, Las Vegas, Nevada
- Shriners Burns Institute, Massachusetts General Hospital, Boston, Massachusetts
- St Elizabeth's Regional Burn Center, Lincoln, Nebraska
- University of Tennessee Medical Group, Memphis, Tennessee
- Burn Trauma Unit, University of Utah Hospital and Clinic, Salt Lake City, Utah
- St. Agnes Burn Center, Philadelphia, Pennsylvania
- Burn Institute–Boston Unit, Shriners Hospital for Children, Boston, Massachusetts
- Department of Surgery, University of Alabama, and Birmingham, Alabama.
- Venue
- The Journal of Burn Care & Rehabilitation
- Publisher
- Oxford University Press (OUP)
- Published
- 2003-01-01
- Volume
- 24
- Issue
- 1
- Pages
- 42-48
- ISSN
- 0273-8481
- 1534-5939
- Cited by
- 325
- References
- 0
- Language
- en
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- Heimbach, D. M., Warden, G. D., Luterman, A., Jordan, M. H., Ozobia, N., Ryan, C. M., Voigt, D. W., Hickerson, W. L., Saffle, J. R., DeClement, F. A., Sheridan, R. L., & Dimick, A. R. (2003). Multicenter postapproval clinical trial of Integra dermal regeneration template for burn treatment. The Journal of Burn Care & Rehabilitation. https://doi.org/10.1097/00004630-200301000-00009
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
