Surgical HemostasisPhase 2NCT00371215
Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting
A Phase 2 study testing rThrombin in people with Surgical Hemostasis, run by ZymoGenetics at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery. Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- Surgical Hemostasis
- What is being tested?
- rThrombin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jun 2007
- Phase
- Phase 2
- 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 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Autologous skin grafting with sheet or mesh grafts following burn or traumatic skin injury
Who cannot join
- Known antibodies or hypersensitivity to thrombin or other coagulation factors
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard M. Fairbanks Burn Center, Wishard Hospital
Indianapolis, Indiana, 46202
About this study
Official title: A Phase 2 Study of Recombinant Human Thrombin (rThrombin) Administered Using a Spray Applicator in Subjects Undergoing Autologous Skin Grafting Following Burn or Traumatic Skin Injury
The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.
Read the detailed description
This is a Phase 2 multiple site, single-arm, open-label study designed to evaluate the safety of rThrombin in subjects of age 2 to 75 years who are receiving a partial- or full-thickness autologous sheet or mesh grafts following burn or traumatic skin injury. After establishing eligibility, study participants will be treated with topical spray rThrombin at the skin graft recipient site during autologous skin graft surgery. There will be a 1-month follow-up period after the surgery.
- Conditions
- Surgical Hemostasis
- Being tested
- rThrombin
- Keywords
- hemostasis, grafting, skin, hemostatics, phase 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rThrombinBiological
1000 U/mL applied topically
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | rThrombin Receives: Biological: rThrombin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events
Measured: Up to day 29
Secondary outcomes (5)
The incidence and grade of clinical laboratory abnormalities
Measured: Up to day 29
The incidence of anti-rThrombin product antibodies
Measured: Up to day 29
The incidence of hemostasis
Measured: Up to 20 minutes
The percentage of graft take
Measured: Up to day 29
The incidence of re-grafting
Measured: Up to day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startAug 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical HemostasisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZymoGenetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Allan Alexander, MD, Study director, ZymoGenetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371215
- Sponsor's protocol ID
- 499E02
- Status last verified
- Mar 2009
- First submitted
- 30 Aug 2006
- Last updated
- 9 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Recombinant Human Thrombin (rThrombin) Administered Using a Spray Applicator in Subjects Undergoing Autologous Skin Grafting Following Burn or Traumatic Skin Injury
- ClinicalTrials.gov ID
- NCT00371215
- Acronym / sponsor ID
- 499E02
- Conditions
- Surgical Hemostasis
- Keywords
- hemostasis, grafting, skin, hemostatics, phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- ZymoGeneticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 1 Sep 2006 (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.
The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.
Detailed description
This is a Phase 2 multiple site, single-arm, open-label study designed to evaluate the safety of rThrombin in subjects of age 2 to 75 years who are receiving a partial- or full-thickness autologous sheet or mesh grafts following burn or traumatic skin injury. After establishing eligibility, study participants will be treated with topical spray rThrombin at the skin graft recipient site during autologous skin graft surgery. There will be a 1-month follow-up period after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: rThrombinrThrombin |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Autologous skin grafting with sheet or mesh grafts following burn or traumatic skin injury
Key exclusion criteria (1 listed)
- Known antibodies or hypersensitivity to thrombin or other coagulation factors
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 |
|---|---|---|
| rThrombin1000 U/mL applied topically | Biological | 1 |
Primary outcome
The incidence and severity of adverse events
Time frame: Up to day 29
5 secondary outcomes
The incidence and grade of clinical laboratory abnormalities
Time frame: Up to day 29
The incidence of anti-rThrombin product antibodies
Time frame: Up to day 29
The incidence of hemostasis
Time frame: Up to 20 minutes
The percentage of graft take
Time frame: Up to day 29
The incidence of re-grafting
Time frame: Up to day 29
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 9 Mar 2009.
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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.
Allan Alexander, MD study director
ZymoGenetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rThrombin in people with Surgical Hemostasis, run by ZymoGenetics 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: finished, as of the sponsor's last update on 9 Mar 2009. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The incidence and severity of adverse events (time frame: Up to day 29). 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 9 Mar 2009.