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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Complete wound closure of skin graft donor site.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Adverse events
Skin graft take

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Renovo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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