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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00426972
Other study ID # RN1002-0066
Secondary ID
Status Completed
Phase Phase 3
First received January 24, 2007
Last updated August 27, 2009
Start date January 2007
Est. completion date October 2008

Study information

Verified date August 2009
Source Renovo
Contact n/a
Is FDA regulated No
Health authority Latvia: State Agency of Medicines
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date October 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
estradiol (Zesteem)


Locations

Country Name City State
Germany Universitatsklinikum Aachen Klinik fur Plastiche Chirurgie Aachen
Germany Klinik fur Dermatologie und Allergologie, Bochum St Josef Hospital Bochum
Germany Universitatsklinik fur Plastiche Chirurgie und Schwerbrandverletze Bochum
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
Germany Klinik fur Plastiche- Hand und Wiederherstellungschirurgie Hannover
Germany Klinik fur Dermatologie, Friedrich-Schiller Universitat Jena Jena
Germany Klinikum Koln-Merheim Abteilung Plastiche-, Rekonstruktive-, Asthetische- Hand- Verbrennungschirurgie Koln
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
Latvia P Stradins Clinical University Hospital Riga
Russian Federation Regional Clinical Hospital, Partizana Krasnoyarsk
Russian Federation City Clinical Hospital # 36 Moscow
Russian Federation City Clinical Hospital # 36 Moscow
Russian Federation City Clinical Hospital #13 Moscow
Russian Federation Russian Medical Academy for Postgraduate Education, Surgery Moscow
Russian Federation The Central Clinical Hospital # 1 of LLC "Russian Railways" Moscow
Russian Federation Research Institute for Traumatology and Orthopaedy, Verhne-Volzhskaya Naberezhnaya Novorogod
Russian Federation City Clinical Hospital # 7 Saratov
Russian Federation Clinical Hospital n.a. N.V. Solovyov Yaroslavl
United Kingdom Pinderfields Hospital Aberford Road Wakefield
United Kingdom Stoke Mandeville Hospital Aylesbury Buckinghamshire
United Kingdom Selly Oak Hospital Birmingham
United Kingdom Broomfield Hospital Chelmsford
United Kingdom McIndoe Burns Unit, Queen Victoria Hospital East Grinstead West Sussex
United Kingdom Wythenshawe Hospital Manchester

Sponsors (1)

Lead Sponsor Collaborator
Renovo

Countries where clinical trial is conducted

Germany,  Latvia,  Russian Federation,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete wound closure of skin graft donor site.
Secondary Adverse events
Secondary Skin graft take
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