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Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00426972
Recruitment Status : Completed
First Posted : January 25, 2007
Last Update Posted : August 28, 2009
Sponsor:
Information provided by:
Renovo

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.

Condition or disease Intervention/treatment Phase
Burn Trauma Varicose Ulcer Drug: estradiol (Zesteem) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double Blind, Placebo Controlled Trial to Investigate the Efficacy of Zesteem (Estradiol) in Accelerating the Healing of Split Thickness Skin Graft Donor Sites.
Study Start Date : January 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Complete wound closure of skin graft donor site.

Secondary Outcome Measures :
  1. Adverse events
  2. Skin graft take


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426972


Locations
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Sponsors and Collaborators
Renovo
Investigators
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Principal Investigator: Ken Dunn, MD Wythenshawe Hospital

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ClinicalTrials.gov Identifier: NCT00426972    
Other Study ID Numbers: RN1002-0066
First Posted: January 25, 2007    Key Record Dates
Last Update Posted: August 28, 2009
Last Verified: August 2009
Additional relevant MeSH terms:
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Varicose Ulcer
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female