Wounds and InjuriesNCT04543240
Bacterial Load for Integra™ in Operative Wounds
An observational study of Wounds and Injuries, run by Georgetown University at 1 site in United States.
Trial summary
Proportion of postoperative complications (infections, dehiscence, graft slough) after initial application of Integra™ Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Integra™ dermal regeneration template
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2017to 1 Jan 2021
- How long will I take part?
- 1 Year
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be anyone who is experiencing partial or full thickness wounds, pressure ulcers, venous and diabetic ulcers, burns, and traumatic wounds.
Who may be able to join
- Male or Female age 18-90.
- Full-thickness wounds below the knee.
- Patients who require, in the opinion of the Investigator, operative application of Integra™.
- Patients able and willing to comply with the study protocol.
Who cannot join
- Male or Female under 18 or over 90
- Patients that do not have Full-thickness wounds below the knee
- Patients who do not require, in the opinion of the Investigator, operative application of Integra™.
- Patients that are not able or willing to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Priscilla Wong, 202-444-1321, pw504@georgetown.edu
About this study
Official title: The Relationship Between Bacterial Load and the Clinical Outcomes for Integra™ in Operative Wounds
Proportion of postoperative complications (infections, dehiscence, graft slough) after initial application of Integra™
Read the detailed description
This is a study examining the use of Integra™ for the treatment of lower extremity wounds to better understand the relationship between bacteria contamination levels and post-operative complications. Wounds requiring operative application of Integra™ alone or Integra™ followed by a planned subsequent application of a STSG will be enrolled into this study.
The tolerance of Integra™ to bacterial bioburden at the time of application will be determined by observing their respective postoperative wound complications and correlating these findings with quantitative bacterial counts, qualitative culture results, and bacterial and wound protease levels at the time of Integra™ alone application or Integra™ followed by STSG application.
Patients will then be followed until complete healing has occurred or until 16 weeks, whichever comes first.
- Conditions
- Wounds and Injuries
- Being tested
- Integra™ dermal regeneration template
- Keywords
- Lower extremity
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integra™ dermal regeneration templateDevice
Integra a biologic dressing for deep wounds or large soft tissue defects that penetrate to the level of bone
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine a threshold in which Integra is tolerant to bacteria that yields positive results (healing). The investigators believe that this device is more tolerant to bacterial load then current perception.
Quantitative CFUs will be obtained by obtaining tissue from the wound at the time of debridement from otherwise discarded tissue. After tissue cultures are obtained and sent to a designated microbial lab for analysis. Tissue culture is to be obtained from the central aspect of the wound bed. These cultures will be processed and analyzed for research purposes. Qualitative cultures will be obtained as per SOC and sent to the local lab per customary fashion.
Qualitative bacterial protease and human inflammation protease indications will be obtained by sampling and testing two separate wound fluid swabs on investigational devices; WOUNDCHEKTM Bacterial Status and WOUNDCHEKTM Protease Status. Bacterial Status detects enzymes that are present when bacteria have become pathogenic while Protease Status detects enzymes present when the wound is in a chronically inflamed state. The tests will be obtained from Woundchek Labs.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start14 Dec 2017
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Responsible party
- Principal investigator, Christopher Attinger, M.D., Georgetown University
- Investigators
- Christopher Attinger, MD, Principal investigator, MedStar Georgetown University Hopsital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543240
- Sponsor's protocol ID
- 2017-0908
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Bacterial Load and the Clinical Outcomes for Integra™ in Operative Wounds
- ClinicalTrials.gov ID
- NCT04543240
- Acronym / sponsor ID
- 2017-0908
- Conditions
- Wounds and Injuries
- Keywords
- Lower extremity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 10 Sep 2020 (actual)
- 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.
Proportion of postoperative complications (infections, dehiscence, graft slough) after initial application of Integra™
Detailed description
This is a study examining the use of Integra™ for the treatment of lower extremity wounds to better understand the relationship between bacteria contamination levels and post-operative complications. Wounds requiring operative application of Integra™ alone or Integra™ followed by a planned subsequent application of a STSG will be enrolled into this study.
The tolerance of Integra™ to bacterial bioburden at the time of application will be determined by observing their respective postoperative wound complications and correlating these findings with quantitative bacterial counts, qualitative culture results, and bacterial and wound protease levels at the time of Integra™ alone application or Integra™ followed by STSG application.
Patients will then be followed until complete healing has occurred or until 16 weeks, whichever comes first.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be anyone who is experiencing partial or full thickness wounds, pressure ulcers, venous and diabetic ulcers, burns, and traumatic wounds.
Key inclusion criteria (4 listed)
- Male or Female age 18-90.
- Full-thickness wounds below the knee.
- Patients who require, in the opinion of the Investigator, operative application of Integra™.
- Patients able and willing to comply with the study protocol.
Key exclusion criteria (4 listed)
- Male or Female under 18 or over 90
- Patients that do not have Full-thickness wounds below the knee
- Patients who do not require, in the opinion of the Investigator, operative application of Integra™.
- Patients that are not able or willing to comply with the study protocol.
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 |
|---|---|---|
| Integra™ dermal regeneration templateIntegra a biologic dressing for deep wounds or large soft tissue defects that penetrate to the level of bone | Device | – |
Primary outcome
Determine a threshold in which Integra is tolerant to bacteria that yields positive results (healing). The investigators believe that this device is more tolerant to bacterial load then current perception.
Time frame: 1 year
Quantitative CFUs will be obtained by obtaining tissue from the wound at the time of debridement from otherwise discarded tissue. After tissue cultures are obtained and sent to a designated microbial lab for analysis. Tissue culture is to be obtained from the central aspect of the wound bed. These cultures will be processed and analyzed for research purposes. Qualitative cultures will be obtained as per SOC and sent to the local lab per customary fashion. Qualitative bacterial protease and human inflammation protease indications will be obtained by sampling and testing two separate wound fluid swabs on investigational devices; WOUNDCHEKTM Bacterial Status and WOUNDCHEKTM Protease Status. Bacterial Status detects enzymes that are present when bacteria have become pathogenic while Protease Status detects enzymes present when the wound is in a chronically inflamed state. The tests will be obtained from Woundchek Labs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Christopher Attinger, MD principal investigator
MedStar Georgetown University Hopsital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injuries, run by Georgetown University 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brittany Spinelli (202.687.6974, bs1114@georgeotown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine a threshold in which Integra is tolerant to bacteria that yields positive results (healing). The investigators believe that this device is more tolerant to bacterial load then current perception. (time frame: 1 year). 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 11 Sep 2020.