BurnPhase 3NCT00426972
Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites
A Phase 3 study testing estradiol (Zesteem) in people with Burn and Trauma, run by Renovo at 30 sites in 4 countries.
Trial summary
This trial will assess the effects of Zesteem (estradiol) on the healing of split thickness skin graft donor sites in patients aged 18-85 years. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Burn, Trauma, Varicose Ulcer
- What is being tested?
- estradiol (Zesteem)
- How many people
- 148 participants
- Where
- 30 sitesin 4 countries
- Study dates
- Jan 2007to Oct 2008
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-85 years who have provided written informed consent.
- Patients requiring skin grafting due to burns, trauma or chronic venous ulcers, with a donor site expected to be between 20 and 200 cm2 on a non-articulated area.
- Female patients of child bearing potential who are using method(s) of contraception acceptable to the Investigator and agree to do so from at least the screening visit until one month after administration of the final study dose.
Who cannot join
- Patients with burns involving more than 15% of their total body area.
- Patients with sepsis, haemodynamic instability requiring pressor support or positive blood microbiology cultures within 48h of surgery.
- Patients with inhalation injury requiring artificial respiratory assistance.
- Patients requiring skin grafts following removal of suspicious skin lesions.
- Patients who have received treatment with systemic steroids during the 30 days prior to surgery.
- Patients who have received immunosuppressive drugs, radiation or chemotherapy during the three months prior to surgery.
Show all 16Show fewer
- Patients with a history of malignancy in the previous three years.
- Patients with uncontrolled diabetes or diabetic ulcers.
- Patients with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerability or efficacy.
- Patients who have previously had skin grafts harvested from the area to be studied.
- Patients with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
- Patients with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
- Patients who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
- Patients undergoing investigations or changes in management for an existing medical condition.
- Patients who are or who become pregnant up to and including Day 0 or who are lactating.
- In the opinion of the Investigator, a patient who is not likely to complete the trial for whatever reason.
Trial locations and contacts
30 sites in 4 countries.
30 sites in 4 countries
Germany14 sites
Universitatsklinikum Aachen Klinik fur Plastiche Chirurgie
Aachen, 52074
Universitatsklinik fur Plastiche Chirurgie und Schwerbrandverletze
Bochum, D-44789
Klinik fur Dermatologie und Allergologie, Bochum St Josef Hospital
Bochum, D-44791
Klinikum Koln-Merheim Abteilung Plastiche-, Rekonstruktive-, Asthetische- Hand- Verbrennungschirurgie
Cologne, 51109
Carl- Thiem- klinikum Cottbus
Cottbus, 03048
Abteilung fur Plastiche und Handchirurgie
Erlangen, 12, 91054
Zentrum der Dermatologie und Venerologie, Johann Wolfgang Institut
Frankfurt, D-D-60590
Universitatsklinikum Freiburg
Freiburg im Breisgau, D-79106
Klinik fur Plastiche- Hand und Wiederherstellungschirurgie
Hanover, 30625
Klinik fur Dermatologie, Friedrich-Schiller Universitat Jena
Jena, 07740
Klinikum St. Georg- Leipzig
Leipzig, D-04129
Otto-von-Gericke Universitat Magdeburg, universitatsklinikum fur Dermatologie und Venerologie
Magdeburg, 39120
Klinik fur Plastiche-Asthetische- u. Handchiurgie. Kinikum Offenbach
Offenbach, D-63069
HSK, Wilhelm Fresenius Klinik
Wiesbaden, 65191
Russia9 sites
Regional Clinical Hospital, Partizana
Krasnoyarsk, 660022
City Clinical Hospital # 36
Moscow, 105187
City Clinical Hospital # 36
Moscow, 111539
Russian Medical Academy for Postgraduate Education, Surgery
Moscow, 113093
City Clinical Hospital #13
Moscow, 115280
The Central Clinical Hospital # 1 of LLC "Russian Railways"
Moscow, 125367
Research Institute for Traumatology and Orthopaedy, Verhne-Volzhskaya Naberezhnaya
Novorogod
City Clinical Hospital # 7
Saratov, 410005
Clinical Hospital n.a. N.V. Solovyov
Yaroslavl
United Kingdom6 sites
Pinderfields Hospital
Aberford Road, Wakefield, WF1 4DG
Stoke Mandeville Hospital
Aylesbury, Buckinghamshire, HP21 8AL
Selly Oak Hospital
Birmingham, B29 6JD
Broomfield Hospital
Chelmsford, CM1 7ET
McIndoe Burns Unit, Queen Victoria Hospital
East Grinstead, West Sussex, RH19 3DZ
Wythenshawe Hospital
Manchester, M23 9LT
About this study
Official title: A Double Blind, Placebo Controlled Trial to Investigate the Efficacy of Zesteem (Estradiol) in Accelerating the Healing of Split Thickness Skin Graft Donor Sites.
This trial will assess the effects of Zesteem (estradiol) on the healing of split thickness skin graft donor sites in patients aged 18-85 years.
- Conditions
- Burn, Trauma, Varicose Ulcer
- Being tested
- estradiol (Zesteem)
- Medical subject headings
- Burns, Wounds and Injuries, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estradiol (Zesteem)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete wound closure of skin graft donor site.
Secondary outcomes (2)
Adverse events
Skin graft take
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionJul 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ken Dunn, MD, Principal investigator, Wythenshawe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426972
- Sponsor's protocol ID
- RN1002-0066
- Status last verified
- Aug 2009
- First submitted
- 24 Jan 2007
- Last updated
- 28 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled Trial to Investigate the Efficacy of Zesteem (Estradiol) in Accelerating the Healing of Split Thickness Skin Graft Donor Sites.
- ClinicalTrials.gov ID
- NCT00426972
- Acronym / sponsor ID
- RN1002-0066
- Conditions
- Burn, Trauma, Varicose Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 25 Jan 2007 (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 trial will assess the effects of Zesteem (estradiol) on the healing of split thickness skin graft donor sites in patients aged 18-85 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-85 years who have provided written informed consent.
- Patients requiring skin grafting due to burns, trauma or chronic venous ulcers, with a donor site expected to be between 20 and 200 cm2 on a non-articulated area.
- Female patients of child bearing potential who are using method(s) of contraception acceptable to the Investigator and agree to do so from at least the screening visit until one month after administration of the final study dose.
Key exclusion criteria (16 listed)
- Patients with burns involving more than 15% of their total body area.
- Patients with sepsis, haemodynamic instability requiring pressor support or positive blood microbiology cultures within 48h of surgery.
- Patients with inhalation injury requiring artificial respiratory assistance.
- Patients requiring skin grafts following removal of suspicious skin lesions.
- Patients who have received treatment with systemic steroids during the 30 days prior to surgery.
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 |
|---|---|---|
| estradiol (Zesteem) | Drug | – |
Primary outcome
Complete wound closure of skin graft donor site.
2 secondary outcomes
Adverse events
Skin graft take
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 28 Aug 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.
Ken Dunn, MD principal investigator
Wythenshawe Hospital
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing estradiol (Zesteem) in people with Burn and Trauma, run by Renovo at 30 sites in 4 countries.
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 16 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 28 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Germany, Russia, United Kingdom, Latvia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Complete wound closure of skin graft donor site.. 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 28 Aug 2009.