Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites (NCT00426972) | Clinical Trial Compass
CompletedPhase 3
Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites
Germany148 participantsStarted 2007-01
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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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 …