Multicenter postapproval clinical trial of Integra® Dermal Regeneration Template for burn treatment

David M. Heimbach, Glenn D. Warden, Arnold Luterman, Marion H. Jordan, Nathan Ozobia, Colleen M. Ryan, David W. Voigt, William Hickerson, Jeffrey R. Saffle, Frederick A. DeClement, Robert L. Sheridan, Alan R. Dimick

Research output: Contribution to journalArticle

176 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)42-48
Number of pages7
JournalJournal of Burn Care and Rehabilitation
Volume24
Issue number1
DOIs
StatePublished - Jan 1 2003

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Autografts
Regeneration
Clinical Trials
Confidence Intervals
Burn Units
Skin
Body Surface Area
Wounds and Injuries
Infection
Safety
Incidence
Therapeutics

All Science Journal Classification (ASJC) codes

  • Surgery
  • Nursing(all)
  • Emergency Medicine
  • Rehabilitation
  • Health Professions(all)

Cite this

Heimbach, D. M., Warden, G. D., Luterman, A., Jordan, M. H., Ozobia, N., Ryan, C. M., ... Dimick, A. R. (2003). Multicenter postapproval clinical trial of Integra® Dermal Regeneration Template for burn treatment. Journal of Burn Care and Rehabilitation, 24(1), 42-48. https://doi.org/10.1097/00004630-200301000-00009

Multicenter postapproval clinical trial of Integra® Dermal Regeneration Template for burn treatment. / Heimbach, David M.; Warden, Glenn D.; Luterman, Arnold; Jordan, Marion H.; Ozobia, Nathan; Ryan, Colleen M.; Voigt, David W.; Hickerson, William; Saffle, Jeffrey R.; DeClement, Frederick A.; Sheridan, Robert L.; Dimick, Alan R.

In: Journal of Burn Care and Rehabilitation, Vol. 24, No. 1, 01.01.2003, p. 42-48.

Research output: Contribution to journalArticle

Heimbach, DM, Warden, GD, Luterman, A, Jordan, MH, Ozobia, N, Ryan, CM, Voigt, DW, Hickerson, W, Saffle, JR, DeClement, FA, Sheridan, RL & Dimick, AR 2003, 'Multicenter postapproval clinical trial of Integra® Dermal Regeneration Template for burn treatment', Journal of Burn Care and Rehabilitation, vol. 24, no. 1, pp. 42-48. https://doi.org/10.1097/00004630-200301000-00009
Heimbach, David M. ; Warden, Glenn D. ; Luterman, Arnold ; Jordan, Marion H. ; Ozobia, Nathan ; Ryan, Colleen M. ; Voigt, David W. ; Hickerson, William ; Saffle, Jeffrey R. ; DeClement, Frederick A. ; Sheridan, Robert L. ; Dimick, Alan R. / Multicenter postapproval clinical trial of Integra® Dermal Regeneration Template for burn treatment. In: Journal of Burn Care and Rehabilitation. 2003 ; Vol. 24, No. 1. pp. 42-48.
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