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

August 27, 2009 updated by: Renovo

A Double Blind, Placebo Controlled Trial to Investigate the Efficacy of Zesteem (Estradiol) in Accelerating the Healing of Split Thickness Skin Graft Donor Sites.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

148

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Complete wound closure of skin graft donor site.

Secondary Outcome Measures

Outcome Measure
Adverse events
Skin graft take

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renovo

Investigators

  • Principal Investigator: Ken Dunn, MD, Wythenshawe Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

January 24, 2007

First Submitted That Met QC Criteria

January 24, 2007

First Posted (Estimate)

January 25, 2007

Study Record Updates

Last Update Posted (Estimate)

August 28, 2009

Last Update Submitted That Met QC Criteria

August 27, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RN1002-0066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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