Decubitus UlcerNCT03482999
Case Series Assessing TissuGlu® Surgical Adhesive in Flap Surgery for Decubitus Repair
An observational study of Decubitus Ulcer, run by Cohera Medical, Inc..
Trial summary
To evaluate the impact of a high strength lysine-based adhesive (TissuGlu® Surgical Adhesive) on complications and revision rates in large flap surgery for decubitus repair. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Decubitus Ulcer
- What is being tested?
- TissuGlu Surgical Adhesive
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 28 Mar 2011to 27 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population included patients undergoing flap surgery for decubitus repair between March 2011 and July 2015. In October 2013, the investigator converted to the use of TissuGlu® Surgical Adhesive in conjunction with surgical drains as their standard of care for flap surgery for decubitus repair. The analysis was performed retrospectively on two consecutive cohort groups.
Who may be able to join
- undergoing a procedure for decubitus repair
- be 22 years of age or older
Who cannot join
- expected flap size less than 5 sqcm
About this study
Official title: Post-Market, Investigator Initiated, Retrospective, Audited Observational Case Series Assessing a Lysine-Derived Urethane Adhesive (TissuGlu® Surgical Adhesive) in Flap Surgery for Decubitus Repair
To evaluate the impact of a high strength lysine-based adhesive (TissuGlu® Surgical Adhesive) on complications and revision rates in large flap surgery for decubitus repair.
Read the detailed description
A total of 50 subjects undergoing flap surgery for decubitus repair at the Clinic for Plastic and Aesthetic Surgery, Hand Surgery, St. Joseph's Hospital in Hagen, Germany were included in a post-market investigator initiated, retrospective observational series study.
- Conditions
- Decubitus Ulcer
- Being tested
- TissuGlu Surgical Adhesive
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TissuGlu Surgical AdhesiveDevice
| Study group | Role | What they receive |
|---|---|---|
| Control | Standard Wound Closure with drains | |
| TissuGlu Surgical Adhesive | TissuGlu was used for approximation and adhesion of the flaps in conjunction with drains Receives: Device: TissuGlu Surgical Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduce the post-operative duration of stay
duration
Measured: 30 days
reduce the surgical revision rate
rate
Measured: 30 days
Secondary outcomes (2)
percent of patients requiring a revision
percent
Measured: 30 days
duration of wound drainage
duration
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start28 Mar 2011
- Primary completion27 Aug 2015
- Study completion27 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decubitus UlcerStudies 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cohera Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482999
- Sponsor's protocol ID
- CLN-100-0025
- Status last verified
- Mar 2018
- First submitted
- 22 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market, Investigator Initiated, Retrospective, Audited Observational Case Series Assessing a Lysine-Derived Urethane Adhesive (TissuGlu® Surgical Adhesive) in Flap Surgery for Decubitus Repair
- ClinicalTrials.gov ID
- NCT03482999
- Acronym / sponsor ID
- CLN-100-0025
- Conditions
- Decubitus Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cohera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2011 (actual)
- Primary completion
- 27 Aug 2015 (actual)
- Study completion
- 27 Aug 2015 (actual)
- First posted
- 29 Mar 2018 (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.
To evaluate the impact of a high strength lysine-based adhesive (TissuGlu® Surgical Adhesive) on complications and revision rates in large flap surgery for decubitus repair.
Detailed description
A total of 50 subjects undergoing flap surgery for decubitus repair at the Clinic for Plastic and Aesthetic Surgery, Hand Surgery, St. Joseph's Hospital in Hagen, Germany were included in a post-market investigator initiated, retrospective observational series study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Standard Wound Closure with drains |
| TissuGlu Surgical Adhesive | – | Device: TissuGlu Surgical AdhesiveTissuGlu was used for approximation and adhesion of the flaps in conjunction with drains |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population included patients undergoing flap surgery for decubitus repair between March 2011 and July 2015. In October 2013, the investigator converted to the use of TissuGlu® Surgical Adhesive in conjunction with surgical drains as their standard of care for flap surgery for decubitus repair. The analysis was performed retrospectively on two consecutive cohort groups.
Key inclusion criteria (2 listed)
- undergoing a procedure for decubitus repair
- be 22 years of age or older
Key exclusion criteria (1 listed)
- expected flap size less than 5 sqcm
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 |
|---|---|---|
| TissuGlu Surgical Adhesive | Device | TissuGlu Surgical Adhesive |
Primary outcome
reduce the post-operative duration of stay
Time frame: 30 days
duration
reduce the surgical revision rate
Time frame: 30 days
rate
2 secondary outcomes
percent of patients requiring a revision
Time frame: 30 days
duration of wound drainage
Time frame: 30 days
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 29 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Decubitus Ulcer, run by Cohera Medical, Inc..
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 2 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 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
reduce the post-operative duration of stay (time frame: 30 days). The study lists 2 primary outcomes in all. 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 29 Mar 2018.