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

This study has been completed.
Sponsor:
Information provided by:
Renovo
ClinicalTrials.gov Identifier:
NCT00426972
First received: January 24, 2007
Last updated: August 27, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Burn
Trauma
Varicose Ulcer
Drug: estradiol (Zesteem)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Renovo:

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

Secondary Outcome Measures:
  • Adverse events
  • Skin graft take

Estimated Enrollment: 148
Study Start Date: January 2007
Study Completion Date: October 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426972

Locations
Germany
Universitatsklinikum Aachen Klinik fur Plastiche Chirurgie
Aachen, Germany, 52074
Klinik fur Dermatologie und Allergologie, Bochum St Josef Hospital
Bochum, Germany, D-44791
Universitatsklinik fur Plastiche Chirurgie und Schwerbrandverletze
Bochum, Germany, D-44789
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
Latvia
P Stradins Clinical University Hospital
Riga, Latvia, LV1002
Russian Federation
Regional Clinical Hospital, Partizana
Krasnoyarsk, Russian Federation, 660022
Russian Medical Academy for Postgraduate Education, Surgery
Moscow, Russian Federation, 113093
City Clinical Hospital #13
Moscow, Russian Federation, 115280
City Clinical Hospital # 36
Moscow, Russian Federation, 105187
The Central Clinical Hospital # 1 of LLC "Russian Railways"
Moscow, Russian Federation, 125367
City Clinical Hospital # 36
Moscow, Russian Federation, 111539
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
Renovo
Investigators
Principal Investigator: Ken Dunn, MD Wythenshawe Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00426972     History of Changes
Other Study ID Numbers: RN1002-0066
Study First Received: January 24, 2007
Last Updated: August 27, 2009
Health Authority: Latvia: State Agency of Medicines

Additional relevant MeSH terms:
Varicose Ulcer
Cardiovascular Diseases
Leg Ulcer
Skin Diseases
Skin Ulcer
Varicose Veins
Vascular Diseases
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Polyestradiol phosphate
Contraceptive Agents
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014