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.
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.
Klinik fur Dermatologie und Allergologie, Bochum St Josef Hospital, Bochum D-44791, Germany; Not yet recruiting
Prof Altmeyer, MD, Principal Investigator
Klinik fur Plastiche-Asthetische- u. Handchiurgie. Kinikum Offenbach, Offenbach D-63069, Germany; Not yet recruiting
Henrik Menke, MD, Principal Investigator
Klinikum St. Georg- Leipzig, Leipzig D-04129, Germany; Not yet recruiting
Thomas Raff, MD, Principal Investigator
Universitatsklinikum Freiburg, Freiburg D-79106, Germany; Not yet recruiting
Bannasch, MD, Principal Investigator
Ziad Kalash, MD, Sub-Investigator
Zentrum der Dermatologie und Venerologie, Johann Wolfgang Institut, Frankfurt D-D-60590, Germany; Not yet recruiting
Kaufmann, MD, Principal Investigator
Universitatsklinik fur Plastiche Chirurgie und Schwerbrandverletze, Bochum D-44789, Germany; Not yet recruiting
Adrian Daigeler, MD, Principal Investigator
Marcus Lehnhardt, MD, Sub-Investigator
HSK, Wilhelm Fresenius Klinik, Wiesbaden 65191, Germany; Not yet recruiting
Bayerl, MD, Principal Investigator
Klinik fur Plastiche- Hand und Wiederherstellungschirurgie, Hannover 30625, Germany; Not yet recruiting
Vogt, MD, Principal Investigator
Abteilung fur Plastiche und Handchirurgie, Erlangen 12, 91054, Germany; Not yet recruiting
Horch, MD, Principal Investigator
Universitatsklinikum Aachen Klinik fur Plastiche Chirurgie, Aachen 52074, Germany; Not yet recruiting
Pallua, MD, Principal Investigator
Carl- Thiem- klinikum Cottbus, Cottbus 03048, Germany; Not yet recruiting
Bachter, MD, Principal Investigator
Otto-von-Gericke Universitat Magdeburg, universitatsklinikum fur Dermatologie und Venerologie, Magdeburg 39120, Germany; Not yet recruiting
Gollnick, MD, Principal Investigator
Klinik fur Dermatologie, Friedrich-Schiller Universitat Jena, Jena 07740, Germany; Not yet recruiting
Kaatz, MD, Principal Investigator
Klinikum Koln-Merheim Abteilung Plastiche-, Rekonstruktive-, Asthetische- Hand- Verbrennungschirurgie, Koln 51109, Germany; Not yet recruiting
A Dencker, MD, Principal Investigator
P Stradins Clinical University Hospital, Riga LV1002, Latvia; Recruiting
Dainis Krievins, MD, Principal Investigator
The Central Clinical Hospital # 1 of LLC "Russian Railways", Moscow 125367, Russian Federation; Not yet recruiting
Alexey Severtsev, Principal Investigator
Russian Medical Academy for Postgraduate Education, Surgery, Moscow 113093, Russian Federation; Not yet recruiting
Andrey Alexeev, Principal Investigator
City Clinical Hospital # 36, Moscow 105187, Russian Federation; Not yet recruiting
Yuriy Tyurnikov, Principal Investigator
City Clinical Hospital # 36, Moscow 111539, Russian Federation; Not yet recruiting
Sergey Goryunov, Principal Investigator
Regional Clinical Hospital, Partizana, Krasnoyarsk 660022, Russian Federation; Not yet recruiting
Valery Ivantsov, Principal Investigator
City Clinical Hospital # 7, Saratov 410005, Russian Federation; Not yet recruiting
Nicolay Ostrovsky, Principal Investigator
Clinical Hospital n.a. N.V. Solovyov, Yaroslavl, Russian Federation; Not yet recruiting
Vladimir Yakusevich, Principal Investigator
Research Institute for Traumatology and Orthopaedy, Verhne-Volzhskaya Naberezhnaya, Novorogod, Russian Federation; Not yet recruiting
Grigory Levin, Principal Investigator
City Clinical Hospital #13, Moscow 115280, Russian Federation; Not yet recruiting
Grigory Rodoman, Principal Investigator
Wythenshawe Hospital, Manchester M23 9LT, United Kingdom; Recruiting
Ken Dunn, MD, Principal Investigator
Selly Oak Hospital, Birmingham B29 6JD, United Kingdom; Recruiting
Naiem Moiemen, Principal Investigator
Broomfield Hospital, Chelmsford CM1 7ET, United Kingdom; Not yet recruiting
Bruce Philp, Principal Investigator
Peter Dziewulski, Sub-Investigator
Stoke Manderville Hospital, Aylesbury, Buckinghamshire HP21 8AL, United Kingdom; Not yet recruiting
Mike Tyler, Principal Investigator
Pinderfields Hospital, Aberford Road, Wakefield WF1 4DG, United Kingdom; Not yet recruiting
Allan Phipps, Principal Investigator
McIndoe Burns Unit, Queen Victoria Hospital, East Grinstead, West Sussex RH19 3DZ, United Kingdom; Recruiting
Phillip Gilbert, Principal Investigator
