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. Identifier: NCT00426972
Recruitment Status : Completed
First Posted : January 25, 2007
Last Update Posted : August 28, 2009
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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

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

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U.S. FDA Resources

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, Senior)
Sexes Eligible for Study:   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.

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 identifier (NCT number): NCT00426972

Universitatsklinikum Aachen Klinik fur Plastiche Chirurgie
Aachen, Germany, 52074
Universitatsklinik fur Plastiche Chirurgie und Schwerbrandverletze
Bochum, Germany, D-44789
Klinik fur Dermatologie und Allergologie, Bochum St Josef Hospital
Bochum, Germany, D-44791
Carl- Thiem- klinikum Cottbus
Cottbus, Germany, 03048
Abteilung fur Plastiche und Handchirurgie
Erlangen, Germany, 12, 91054
Zentrum der Dermatologie und Venerologie, Johann Wolfgang Institut
Frankfurt, Germany, D-D-60590
Universitatsklinikum Freiburg
Freiburg, Germany, D-79106
Klinik fur Plastiche- Hand und Wiederherstellungschirurgie
Hannover, Germany, 30625
Klinik fur Dermatologie, Friedrich-Schiller Universitat Jena
Jena, Germany, 07740
Klinikum Koln-Merheim Abteilung Plastiche-, Rekonstruktive-, Asthetische- Hand- Verbrennungschirurgie
Koln, Germany, 51109
Klinikum St. Georg- Leipzig
Leipzig, Germany, D-04129
Otto-von-Gericke Universitat Magdeburg, universitatsklinikum fur Dermatologie und Venerologie
Magdeburg, Germany, 39120
Klinik fur Plastiche-Asthetische- u. Handchiurgie. Kinikum Offenbach
Offenbach, Germany, D-63069
HSK, Wilhelm Fresenius Klinik
Wiesbaden, Germany, 65191
P Stradins Clinical University Hospital
Riga, Latvia, LV1002
Russian Federation
Regional Clinical Hospital, Partizana
Krasnoyarsk, Russian Federation, 660022
City Clinical Hospital # 36
Moscow, Russian Federation, 105187
City Clinical Hospital # 36
Moscow, Russian Federation, 111539
Russian Medical Academy for Postgraduate Education, Surgery
Moscow, Russian Federation, 113093
City Clinical Hospital #13
Moscow, Russian Federation, 115280
The Central Clinical Hospital # 1 of LLC "Russian Railways"
Moscow, Russian Federation, 125367
Research Institute for Traumatology and Orthopaedy, Verhne-Volzhskaya Naberezhnaya
Novorogod, Russian Federation
City Clinical Hospital # 7
Saratov, Russian Federation, 410005
Clinical Hospital n.a. N.V. Solovyov
Yaroslavl, Russian Federation
United Kingdom
Stoke Mandeville Hospital
Aylesbury, Buckinghamshire, United Kingdom, HP21 8AL
Pinderfields Hospital
Aberford Road, Wakefield, United Kingdom, WF1 4DG
McIndoe Burns Unit, Queen Victoria Hospital
East Grinstead, West Sussex, United Kingdom, RH19 3DZ
Selly Oak Hospital
Birmingham, United Kingdom, B29 6JD
Broomfield Hospital
Chelmsford, United Kingdom, CM1 7ET
Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Principal Investigator: Ken Dunn, MD Wythenshawe Hospital Identifier: NCT00426972     History of Changes
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:
Varicose Ulcer
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female