Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites
NCT ID: NCT00426972
Last Updated: 2009-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
148 participants
INTERVENTIONAL
2007-01-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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estradiol (Zesteem)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Renovo
INDUSTRY
Principal Investigators
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Ken Dunn, MD
Role: PRINCIPAL_INVESTIGATOR
Wythenshawe Hospital
Locations
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Universitatsklinikum Aachen Klinik fur Plastiche Chirurgie
Aachen, , Germany
Universitatsklinik fur Plastiche Chirurgie und Schwerbrandverletze
Bochum, , Germany
Klinik fur Dermatologie und Allergologie, Bochum St Josef Hospital
Bochum, , Germany
Klinikum Koln-Merheim Abteilung Plastiche-, Rekonstruktive-, Asthetische- Hand- Verbrennungschirurgie
Cologne, , Germany
Carl- Thiem- klinikum Cottbus
Cottbus, , Germany
Abteilung fur Plastiche und Handchirurgie
Erlangen, , Germany
Zentrum der Dermatologie und Venerologie, Johann Wolfgang Institut
Frankfurt, , Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, , Germany
Klinik fur Plastiche- Hand und Wiederherstellungschirurgie
Hanover, , Germany
Klinik fur Dermatologie, Friedrich-Schiller Universitat Jena
Jena, , Germany
Klinikum St. Georg- Leipzig
Leipzig, , Germany
Otto-von-Gericke Universitat Magdeburg, universitatsklinikum fur Dermatologie und Venerologie
Magdeburg, , Germany
Klinik fur Plastiche-Asthetische- u. Handchiurgie. Kinikum Offenbach
Offenbach, , Germany
HSK, Wilhelm Fresenius Klinik
Wiesbaden, , Germany
P Stradins Clinical University Hospital
Riga, , Latvia
Regional Clinical Hospital, Partizana
Krasnoyarsk, , Russia
City Clinical Hospital # 36
Moscow, , Russia
City Clinical Hospital # 36
Moscow, , Russia
Russian Medical Academy for Postgraduate Education, Surgery
Moscow, , Russia
City Clinical Hospital #13
Moscow, , Russia
The Central Clinical Hospital # 1 of LLC "Russian Railways"
Moscow, , Russia
Research Institute for Traumatology and Orthopaedy, Verhne-Volzhskaya Naberezhnaya
Novorogod, , Russia
City Clinical Hospital # 7
Saratov, , Russia
Clinical Hospital n.a. N.V. Solovyov
Yaroslavl, , Russia
Stoke Mandeville Hospital
Aylesbury, Buckinghamshire, United Kingdom
Pinderfields Hospital
Aberford Road, Wakefield, United Kingdom
McIndoe Burns Unit, Queen Victoria Hospital
East Grinstead, West Sussex, United Kingdom
Selly Oak Hospital
Birmingham, , United Kingdom
Broomfield Hospital
Chelmsford, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Countries
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Other Identifiers
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RN1002-0066
Identifier Type: -
Identifier Source: org_study_id