NCT00426972CompletedPhase 3
A Double Blind, Placebo Controlled Trial to Investigate the Efficacy of Zesteem (Estradiol) in Accelerating the Healing of Split Thickness Skin Graft Donor Sites.
Renovo59 sites in 5 countries148 target enrollmentStarted: January 1, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 148
- Locations
- 59
- Primary Endpoint
- Complete wound closure of skin graft donor site.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Complete wound closure of skin graft donor site.
Secondary Outcomes
- Skin graft take
- Adverse events
Investigators
Study Sites (59)
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