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Study was stopped due to feasibility issues with completing the study procedure.
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This is a prospective, descriptive, pilot case series involving patients with significant burns who are candidates for reconstruction with Integra®. Subjects would have a small area of the wound would, at the time of excision, have the smallest sheet of thin Integra® (125 cm2) placed and be immediately autografted with a 3:1 meshed split-thickness skin graft. Of note, 125 cm2 represents approximately 0.7% of an average sized patient's total body surface area, so for even the smallest burns in our proposed trial, this area would represent a small portion of the patient's area of injury. The remaining injury areas would be covered with standard-thickness Integra® only.
Integra®, a synthetic dermal substitute, has been utilized in burn care for decades. Typically, 10-14 days after Integra® placement, a patient returns to the operating room, the top silastic layer of the Integra® is removed, and an autograft - a split-thickness skin graft harvested from the patient - is applied directly on top of the incorporated Integra®. The result is regarded to be a cosmetically and functionally superior result to that which would have been obtained had the wound bed itself been autografted at the time of excision, as opposed to being covered by Integra® and autografted during a second operation.
Integra® use in single-stage procedures to cover defects without grafting has shown benefit when defects are fairly small, e.g. fingertip injuries, and small head and neck skin cancer resections. While single-stage reconstruction with Integra® has been demonstrated with standard thickness Integra®, this decreased thickness would increase the likelihood of graft survival due to the decreased distance of nutrient diffusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-stage Integra | Experimental | Composed of a porous collagen-chondroitin 6-sulfate fibrillary mat covered with a thin sheet of silastic, it serves to cover wound beds of freshly excised burns and allow for the infiltration of fibroblasts, capillaries, and macrophages, essentially creating a "neodermis" while also acting as a barrier against infection and a blockade against heat and moisture loss |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thin Integra® (125 cm2) | Device | 125 cm2 represents approximately 0.7% of an average sized patient's total body surface area. The remaining injury areas would be covered with standard-thickness Integra® only. The donor graft, a 4 cm x 10 cm sheet of skin, would be meshed in a 3:1 ratio to be expanded to cover the 125 cm2 sheet of thin Integra®. The patient's post-operative care would be largely unchanged, although the patient would have a donor site of 40 cm2 that would be dressed and managed in the usual fashion. |
| Measure | Description | Time Frame |
|---|---|---|
| The Time to 95% Healing of the Single-stage Reconstructed Skin Graft | 95% healing determined as charted in Standard of Care follow up visits | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Complications: Infection, Seroma, Hematoma, Sloughing, and Graft Loss | Compared to the same characteristics of the adjacent (control) 125 cm2 skin graft | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Mohr, MD | Regions Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3048216 | Background | Heimbach D, Luterman A, Burke J, Cram A, Herndon D, Hunt J, Jordan M, McManus W, Solem L, Warden G, et al. Artificial dermis for major burns. A multi-center randomized clinical trial. Ann Surg. 1988 Sep;208(3):313-20. doi: 10.1097/00000658-198809000-00008. | |
| 19864070 | Background | Nguyen DQ, Potokar TS, Price P. An objective long-term evaluation of Integra (a dermal skin substitute) and split thickness skin grafts, in acute burns and reconstructive surgery. Burns. 2010 Feb;36(1):23-8. doi: 10.1016/j.burns.2009.07.011. Epub 2009 Oct 27. |
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We do not plan to share IPD
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-stage Integra | Composed of a porous collagen-chondroitin 6-sulfate fibrillary mat covered with a thin sheet of silastic, it serves to cover wound beds of freshly excised burns and allow for the infiltration of fibroblasts, capillaries, and macrophages, essentially creating a "neodermis" while also acting as a barrier against infection and a blockade against heat and moisture loss thin Integra® (125 cm2): 125 cm2 represents approximately 0.7% of an average sized patient's total body surface area. The remaining injury areas would be covered with standard-thickness Integra® only. The donor graft, a 4 cm x 10 cm sheet of skin, would be meshed in a 3:1 ratio to be expanded to cover the 125 cm2 sheet of thin Integra®. The patient's post-operative care would be largely unchanged, although the patient would have a donor site of 40 cm2 that would be dressed and managed in the usual fashion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-stage Integra | Composed of a porous collagen-chondroitin 6-sulfate fibrillary mat covered with a thin sheet of silastic, it serves to cover wound beds of freshly excised burns and allow for the infiltration of fibroblasts, capillaries, and macrophages, essentially creating a "neodermis" while also acting as a barrier against infection and a blockade against heat and moisture loss thin Integra® (125 cm2): 125 cm2 represents approximately 0.7% of an average sized patient's total body surface area. The remaining injury areas would be covered with standard-thickness Integra® only. The donor graft, a 4 cm x 10 cm sheet of skin, would be meshed in a 3:1 ratio to be expanded to cover the 125 cm2 sheet of thin Integra®. The patient's post-operative care would be largely unchanged, although the patient would have a donor site of 40 cm2 that would be dressed and managed in the usual fashion. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Time to 95% Healing of the Single-stage Reconstructed Skin Graft | 95% healing determined as charted in Standard of Care follow up visits | Only two patients were enrolled in this study, and they were withdrawn from the trial prior to initiation of the intervention due to patient characteristics. No data was collected on the two withdrawn patients since the study intervention (graft) was not applied to either subject. | Posted | Up to 12 months |
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Adverse events were documented from the time of study enrollment (consenting) until the completion of study activities at 12 months (or until the patients were withdrawn from the study).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-stage Integra | Composed of a porous collagen-chondroitin 6-sulfate fibrillary mat covered with a thin sheet of silastic, it serves to cover wound beds of freshly excised burns and allow for the infiltration of fibroblasts, capillaries, and macrophages, essentially creating a "neodermis" while also acting as a barrier against infection and a blockade against heat and moisture loss thin Integra® (125 cm2): 125 cm2 represents approximately 0.7% of an average sized patient's total body surface area. The remaining injury areas would be covered with standard-thickness Integra® only. The donor graft, a 4 cm x 10 cm sheet of skin, would be meshed in a 3:1 ratio to be expanded to cover the 125 cm2 sheet of thin Integra®. The patient's post-operative care would be largely unchanged, although the patient would have a donor site of 40 cm2 that would be dressed and managed in the usual fashion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Non-systematic Assessment | Patient was noted to have left-sided weakness during examination during hospital stay following intervention. Imaging revealed occlusion of the right carotid artery which was consistent with the patient's symptoms |
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Both subjects were withdrawn by the PI due to their disease state. While subjects were deemed eligible at time of screening and consent upon surgical procedure the patients were deemed too unstable or inappropriate for the study treatment. Patients were notified of this and no further study activities were completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua S Rosenzweig / Study Coordinator | Regions Hospital | 651-254-3351 | joshua.s.rosenzweig@healthpartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2015 | Jan 10, 2023 | Prot_SAP_000.pdf |
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| 17828040 | Background | Branski LK, Herndon DN, Pereira C, Mlcak RP, Celis MM, Lee JO, Sanford AP, Norbury WB, Zhang XJ, Jeschke MG. Longitudinal assessment of Integra in primary burn management: a randomized pediatric clinical trial. Crit Care Med. 2007 Nov;35(11):2615-23. doi: 10.1097/01.CCM.0000285991.36698.E2. |
| 12352131 | Background | Ryan CM, Schoenfeld DA, Malloy M, Schulz JT 3rd, Sheridan RL, Tompkins RG. Use of Integra artificial skin is associated with decreased length of stay for severely injured adult burn survivors. J Burn Care Rehabil. 2002 Sep-Oct;23(5):311-7. doi: 10.1097/00004630-200209000-00002. |
| 24426936 | Background | Jacoby SM, Bachoura A, Chen NC, Shin EK, Katolik LI. One-stage Integra coverage for fingertip injuries. Hand (N Y). 2013 Sep;8(3):291-5. doi: 10.1007/s11552-013-9513-x. |
| 19254877 | Background | Burd A, Wong PS. One-stage Integra reconstruction in head and neck defects. J Plast Reconstr Aesthet Surg. 2010 Mar;63(3):404-9. doi: 10.1016/j.bjps.2008.11.105. Epub 2009 Feb 28. |
| 26649312 | Background | De Angelis B, Gentile P, Tati E, Bottini DJ, Bocchini I, Orlandi F, Pepe G, Di Segni C, Cervelli G, Cervelli V. One-Stage Reconstruction of Scalp after Full-Thickness Oncologic Defects Using a Dermal Regeneration Template (Integra). Biomed Res Int. 2015;2015:698385. doi: 10.1155/2015/698385. Epub 2015 Nov 16. |
| 23963344 | Background | Demiri E, Papaconstantinou A, Dionyssiou D, Dionyssopoulos A, Kaidoglou K, Efstratiou I. Reconstruction of skin avulsion injuries of the upper extremity with integra((R)) dermal regeneration template and skin grafts in a single-stage procedure. Arch Orthop Trauma Surg. 2013 Nov;133(11):1521-6. doi: 10.1007/s00402-013-1834-2. Epub 2013 Aug 21. |
| 22047827 | Background | Kosutic D, Beasung E, Dempsey M, Ryan L, Fauzi Z, O'Sullyvan B, Orr D. Single-layer Integra for one-stage reconstruction of scalp defects with exposed bone following full-thickness burn injury: a novel technique. Burns. 2012 Feb;38(1):143-5. doi: 10.1016/j.burns.2011.08.019. Epub 2011 Nov 1. No abstract available. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Frequency of Complications: Infection, Seroma, Hematoma, Sloughing, and Graft Loss | Compared to the same characteristics of the adjacent (control) 125 cm2 skin graft | No patient data was collected due to physician decision to withdraw the patient from the trial prior to initiation of the intervention. No data was collected on the two withdrawn patients since the study intervention (graft) was not applied to either subject. | Posted | Up to 12 months |
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