Complex Lower Extremity Soft Tissue ReconstructionNCT01947387
Retrospective Study Evaluating Outcomes for Integra® Skin Sheet Products in Lower Extremity Complex Wounds
An observational study of Complex Lower Extremity Soft Tissue Reconstruction, run by Integra LifeSciences Corporation at 4 sites in United States.
Trial summary
This is a retrospective, multi-center study evaluating the outcomes of using Integra® skin sheet bilayer or single layer products for complex soft tissue reconstruction of lower extremity diabetic wounds compared to other treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Lower Extremity Soft Tissue Reconstruction
- How many people
- 320 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2013to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who received Integra, free flap, local tissue flap, or negative pressure wound therapy over a 5-year period. The patient must be a minimum of 1 year from the index procedure, any follow-up occurring during the year is eligible for inclusion.
Who may be able to join
- Diabetic (I or II) male or female, age greater than 18 years
- Lower extremity wounds that required operative application of Integra, free flap, local tissue flap, or negative pressure wound therapy. Complex wounds are defined as wounds that involve exposed deep tissue (e.g. bone, tendon, fascia, ligament)
- The patient must be a minimum of 1 year from the index procedure, any follow-up occurring during the year is eligible for inclusion.
Who cannot join
- Age less than 18 years
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Brigham and Women's Hospital, Inc
Boston, Massachusetts, 02115
Northwestern University Feinberg School of Medicine Division of Plastic Surgery
Chicago, Illinois, 60611
University of Texas Southwestern Medical Ceter
Dallas, Texas, 75390
Georgetown University Hospital Wound Healing Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Retrospective, Multi-Center Study Evaluating the Outcomes for Integra® Skin Sheet Bilayer or Single Layer Products Used in Complex Lower Extremity Soft Tissue Reconstruction
This is a retrospective, multi-center study evaluating the outcomes of using Integra® skin sheet bilayer or single layer products for complex soft tissue reconstruction of lower extremity diabetic wounds compared to other treatments. Participating sites will collect information for all patients who received Integra, free flap, local tissue flap, or negative pressure therapy over a 5 year period. The patient must be a minimum of 1 year from index procedure, with index procedure being defined as the application of Integra, free flap, local tissue flap, or negative pressure. Any follow-up occurring during the year is eligible for inclusion.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Integra | Not described | |
| Integra + NPWT (short-inpatient use only) | Not described | |
| Integra + NPWT (long-all other durations) | Not described | |
| Integra + STSG | Not described | |
| Integra + Dermoinductive Agent | Not described | |
| Free Flap | Not described | |
| Local Tissue Flap | Not described | |
| NPWT | Not described | |
| NPWT then Integra (on same admission) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound recurrence rates after Integra application (and final split-thickness skin graft or dermoinductive agent application) as compared with free flap, local tissue flap, and negative pressure wound therapy.
A dermoinductive agent is a product that is said to promote rapid wound healing.
Measured: 5 year period
Secondary outcomes (1)
Time to ambulation/return to function after Integra application, free flap, local tissue flap, or negative pressure wound therapy.
Measured: 5 year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Lower Extremity Soft Tissue ReconstructionStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Georgetown University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947387
- Sponsor's protocol ID
- Integra 11-2011
- Status last verified
- Dec 2016
- First submitted
- 12 Aug 2013
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multi-Center Study Evaluating the Outcomes for Integra® Skin Sheet Bilayer or Single Layer Products Used in Complex Lower Extremity Soft Tissue Reconstruction
- ClinicalTrials.gov ID
- NCT01947387
- Acronym / sponsor ID
- Integra 11-2011
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Georgetown University
- Study start
- Aug 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
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 retrospective, multi-center study evaluating the outcomes of using Integra® skin sheet bilayer or single layer products for complex soft tissue reconstruction of lower extremity diabetic wounds compared to other treatments. Participating sites will collect information for all patients who received Integra, free flap, local tissue flap, or negative pressure therapy over a 5 year period. The patient must be a minimum of 1 year from index procedure, with index procedure being defined as the application of Integra, free flap, local tissue flap, or negative pressure. Any follow-up occurring during the year is eligible for inclusion.
Study design
- Time perspective
- Retrospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Integra | – | – |
| Integra + NPWT (short-inpatient use only) | – | – |
| Integra + NPWT (long-all other durations) | – | – |
| Integra + STSG | – | – |
| Integra + Dermoinductive Agent | – | – |
| Free Flap | – | – |
| Local Tissue Flap | – | – |
| NPWT | – | – |
| NPWT then Integra (on same admission) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who received Integra, free flap, local tissue flap, or negative pressure wound therapy over a 5-year period. The patient must be a minimum of 1 year from the index procedure, any follow-up occurring during the year is eligible for inclusion.
Key inclusion criteria (3 listed)
- Diabetic (I or II) male or female, age greater than 18 years
- Lower extremity wounds that required operative application of Integra, free flap, local tissue flap, or negative pressure wound therapy. Complex wounds are defined as wounds that involve exposed deep tissue (e.g. bone, tendon, fascia, ligament)
- The patient must be a minimum of 1 year from the index procedure, any follow-up occurring during the year is eligible for inclusion.
Key exclusion criteria (1 listed)
- Age less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Wound recurrence rates after Integra application (and final split-thickness skin graft or dermoinductive agent application) as compared with free flap, local tissue flap, and negative pressure wound therapy.
Time frame: 5 year period
A dermoinductive agent is a product that is said to promote rapid wound healing.
1 secondary outcome
Time to ambulation/return to function after Integra application, free flap, local tissue flap, or negative pressure wound therapy.
Time frame: 5 year period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Lower Extremity Soft Tissue Reconstruction, run by Integra LifeSciences Corporation at 4 sites 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 3 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: finished, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Wound recurrence rates after Integra application (and final split-thickness skin graft or dermoinductive agent application) as compared with free flap, local tissue flap, and negative pressure wound therapy. (time frame: 5 year period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2016.