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

This study is currently recruiting participants.
Verified by Renovo, September 2007

Sponsored by: Renovo
Information provided by: Renovo
ClinicalTrials.gov Identifier: NCT00426972
  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 III

MedlinePlus related topics:   Burns   

ChemIDplus related topics:   Depogen    Estradiol    Estradiol 3-benzoate    Estradiol acetate    Estradiol cypionate    Estradiol dipropionate    Estradiol valerate    Polyestradiol phosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.

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

  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

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

Contacts
Contact: mark cooper, MSc     +441616037630     mark.cooper@renovo.com    

Locations
Germany
Klinik fur Dermatologie und Allergologie, Bochum St Josef Hospital     Not yet recruiting
      Bochum, Germany, D-44791
      Principal Investigator: Prof Altmeyer, MD            
Klinik fur Plastiche-Asthetische- u. Handchiurgie. Kinikum Offenbach     Not yet recruiting
      Offenbach, Germany, D-63069
      Principal Investigator: Henrik Menke, MD            
Klinikum St. Georg- Leipzig     Not yet recruiting
      Leipzig, Germany, D-04129
      Principal Investigator: Thomas Raff, MD            
HSK, Wilhelm Fresenius Klinik     Not yet recruiting
      Wiesbaden, Germany, 65191
      Principal Investigator: Bayerl, MD            
Zentrum der Dermatologie und Venerologie, Johann Wolfgang Institut     Not yet recruiting
      Frankfurt, Germany, D-D-60590
      Principal Investigator: Kaufmann, MD            
Universitatsklinik fur Plastiche Chirurgie und Schwerbrandverletze     Not yet recruiting
      Bochum, Germany, D-44789
      Principal Investigator: Adrian Daigeler, MD            
      Sub-Investigator: Marcus Lehnhardt, MD            
Universitatsklinikum Freiburg     Not yet recruiting
      Freiburg, Germany, D-79106
      Principal Investigator: Bannasch, MD            
      Sub-Investigator: Ziad Kalash, MD            
Klinik fur Plastiche- Hand und Wiederherstellungschirurgie     Not yet recruiting
      Hannover, Germany, 30625
      Principal Investigator: Vogt, MD            
Abteilung fur Plastiche und Handchirurgie     Not yet recruiting
      Erlangen, Germany, 12, 91054
      Principal Investigator: Horch, MD            
Universitatsklinikum Aachen Klinik fur Plastiche Chirurgie     Not yet recruiting
      Aachen, Germany, 52074
      Principal Investigator: Pallua, MD            
Carl- Thiem- klinikum Cottbus     Not yet recruiting
      Cottbus, Germany, 03048
      Principal Investigator: Bachter, MD            
Otto-von-Gericke Universitat Magdeburg, universitatsklinikum fur Dermatologie und Venerologie     Not yet recruiting
      Magdeburg, Germany, 39120
      Principal Investigator: Gollnick, MD            
Klinik fur Dermatologie, Friedrich-Schiller Universitat Jena     Not yet recruiting
      Jena, Germany, 07740
      Principal Investigator: Kaatz, MD            
Klinikum Koln-Merheim Abteilung Plastiche-, Rekonstruktive-, Asthetische- Hand- Verbrennungschirurgie     Not yet recruiting
      Koln, Germany, 51109
      Principal Investigator: A Dencker, MD            
Latvia
P Stradins Clinical University Hospital     Recruiting
      Riga, Latvia, LV1002
      Principal Investigator: Dainis Krievins, MD            
Russian Federation
The Central Clinical Hospital # 1 of LLC "Russian Railways"     Not yet recruiting
      Moscow, Russian Federation, 125367
      Principal Investigator: Alexey Severtsev            
Russian Medical Academy for Postgraduate Education, Surgery     Not yet recruiting
      Moscow, Russian Federation, 113093
      Principal Investigator: Andrey Alexeev            
City Clinical Hospital # 36     Not yet recruiting
      Moscow, Russian Federation, 105187
      Principal Investigator: Yuriy Tyurnikov            
City Clinical Hospital # 36     Not yet recruiting
      Moscow, Russian Federation, 111539
      Principal Investigator: Sergey Goryunov            
Research Institute for Traumatology and Orthopaedy, Verhne-Volzhskaya Naberezhnaya     Not yet recruiting
      Novorogod, Russian Federation
      Principal Investigator: Grigory Levin            
City Clinical Hospital # 7     Not yet recruiting
      Saratov, Russian Federation, 410005
      Principal Investigator: Nicolay Ostrovsky            
Clinical Hospital n.a. N.V. Solovyov     Not yet recruiting
      Yaroslavl, Russian Federation
      Principal Investigator: Vladimir Yakusevich            
Regional Clinical Hospital, Partizana     Not yet recruiting
      Krasnoyarsk, Russian Federation, 660022
      Principal Investigator: Valery Ivantsov            
City Clinical Hospital #13     Not yet recruiting
      Moscow, Russian Federation, 115280
      Principal Investigator: Grigory Rodoman            
United Kingdom
Wythenshawe Hospital     Recruiting
      Manchester, United Kingdom, M23 9LT
      Principal Investigator: Ken Dunn, MD            
Selly Oak Hospital     Recruiting
      Birmingham, United Kingdom, B29 6JD
      Principal Investigator: Naiem Moiemen            
Broomfield Hospital     Not yet recruiting
      Chelmsford, United Kingdom, CM1 7ET
      Principal Investigator: Bruce Philp            
      Sub-Investigator: Peter Dziewulski            
United Kingdom, Buckinghamshire
Stoke Manderville Hospital     Not yet recruiting
      Aylesbury, Buckinghamshire, United Kingdom, HP21 8AL
      Principal Investigator: Mike Tyler            
United Kingdom, Wakefield
Pinderfields Hospital     Not yet recruiting
      Aberford Road, Wakefield, United Kingdom, WF1 4DG
      Principal Investigator: Allan Phipps            
United Kingdom, West Sussex
McIndoe Burns Unit, Queen Victoria Hospital     Recruiting
      East Grinstead, West Sussex, United Kingdom, RH19 3DZ
      Principal Investigator: Phillip Gilbert            

Sponsors and Collaborators
Renovo

Investigators
Principal Investigator:     ken dunn, MD     Wythenshawe Hospital    
  More Information

Study ID Numbers:   RN1002-0066
First Received:   January 24, 2007
Last Updated:   September 11, 2007
ClinicalTrials.gov Identifier:   NCT00426972
Health Authority:   Latvia: State Agency of Medicines

Study placed in the following topic categories:
Burns
Skin Diseases
Benzoates
Ulcer
Estradiol valerate
Wounds and Injuries
Vascular Diseases
Estradiol 17 beta-cypionate
Estradiol
Varicose Ulcer
Varicose Veins
Estradiol 3-benzoate
Polyestradiol phosphate
Skin Ulcer
Leg Ulcer

Additional relevant MeSH terms:
Estrogens
Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Diseases
Reproductive Control Agents
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2008




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