Thermal BurnIntegraNCT03077087
Single-Stage Integra Reconstruction in Burns
A study testing thin Integra® (125 cm2) in people with Thermal Burn, run by HealthPartners Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 125 years
- Conditions the study is for
- Thermal Burn
- What is being tested?
- thin Integra® (125 cm2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2017to 24 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 125 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking adult burn patients greater than 18 years old, admitted with burn injuries eligible for Integra® reconstruction at the discretion of the burn attending physicians.
Who cannot join
- patients with isolated hand or face burns - these burns are treated with sheet grafts (unmeshed); the 3:1 mesh grafts would not be used on these cosmetically sensitive areas. If they have hand and/or face burns in addition to other areas, they will not be excluded. However, the study itself will not be performed on the hands or face. Additionally, patients unable to present to our clinic for routine follow-up due to geographic limitations or otherwise will be ineligible.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Thermal Burn
- Being tested
- thin Integra® (125 cm2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thin Integra® (125 cm2)Device
Also called Integra®
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: thin Integra® (125 cm2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Time to 95% Healing of the Single-stage Reconstructed Skin Graft
95% healing determined as charted in Standard of Care follow up visits
Measured: Up to 12 months
Secondary outcomes (1)
Frequency of Complications: Infection, Seroma, Hematoma, Sloughing, and Graft Loss
Compared to the same characteristics of the adjacent (control) 125 cm2 skin graft
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start10 Apr 2017
- Primary completion24 Jul 2019
- Study completion24 Jul 2019
Why it stopped: Study was stopped due to feasibility issues with completing the study procedure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Thermal BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Mohr, MD, Principal investigator, Regions Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077087
- Sponsor's protocol ID
- A16-734
- Acronym
- Integra
- Status last verified
- Sep 2019
- First submitted
- 27 Feb 2017
- Last updated
- 14 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We do not plan to share IPD
Publications
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.
PubMed 3048216Nguyen 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.
PubMed 19864070Branski 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.
PubMed 17828040Ryan 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.
PubMed 12352131Jacoby 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.
PubMed 24426936Burd 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.
PubMed 19254877De 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.
PubMed 26649312Demiri 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.
PubMed 23963344Kosutic 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.
PubMed 22047827
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Stage Integra Reconstruction in Burns
- ClinicalTrials.gov ID
- NCT03077087
- Acronym / sponsor ID
- Integra / A16-734
- Conditions
- Thermal Burn
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to feasibility issues with completing the study procedure.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Posted 14 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-stage Integra | Experimental | Device: thin Integra® (125 cm2)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 |
Who may qualify
- Ages
- 18 to 125 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking adult burn patients greater than 18 years old, admitted with burn injuries eligible for Integra® reconstruction at the discretion of the burn attending physicians.
Key exclusion criteria (1 listed)
- patients with isolated hand or face burns - these burns are treated with sheet grafts (unmeshed); the 3:1 mesh grafts would not be used on these cosmetically sensitive areas. If they have hand and/or face burns in addition to other areas, they will not be excluded. However, the study itself will not be performed on the hands or face. Additionally, patients unable to present to our clinic for routine follow-up due to geographic limitations or otherwise will be ineligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thin Integra® (125 cm2)Also: Integra®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. | Device | Single-stage Integra |
Primary outcome
The Time to 95% Healing of the Single-stage Reconstructed Skin Graft
Time frame: Up to 12 months
95% healing determined as charted in Standard of Care follow up visits
1 secondary outcome
Frequency of Complications: Infection, Seroma, Hematoma, Sloughing, and Graft Loss
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3048216Heimbach 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.
- Background: PubMed 19864070Nguyen 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.
- Background: PubMed 17828040Branski 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.
- Background: PubMed 12352131Ryan 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.
- Background: PubMed 24426936Jacoby 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.
- Background: PubMed 19254877Burd 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.
- Background: PubMed 26649312De 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.
- Background: PubMed 23963344Demiri 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.
- Background: PubMed 22047827Kosutic 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.
- Individual participant dataSharing planned: No. We do not plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Mohr, MD principal investigator
Regions Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thin Integra® (125 cm2) in people with Thermal Burn, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Time to 95% Healing of the Single-stage Reconstructed Skin Graft (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03077087, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.