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

Primary Purpose

Burn, Trauma, Varicose Ulcer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
estradiol (Zesteem)
Sponsored by
Renovo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universitatsklinikum Aachen Klinik fur Plastiche Chirurgie
  • Universitatsklinik fur Plastiche Chirurgie und Schwerbrandverletze
  • Klinik fur Dermatologie und Allergologie, Bochum St Josef Hospital
  • Carl- Thiem- klinikum Cottbus
  • Abteilung fur Plastiche und Handchirurgie
  • Zentrum der Dermatologie und Venerologie, Johann Wolfgang Institut
  • Universitatsklinikum Freiburg
  • Klinik fur Plastiche- Hand und Wiederherstellungschirurgie
  • Klinik fur Dermatologie, Friedrich-Schiller Universitat Jena
  • Klinikum Koln-Merheim Abteilung Plastiche-, Rekonstruktive-, Asthetische- Hand- Verbrennungschirurgie
  • Klinikum St. Georg- Leipzig
  • Otto-von-Gericke Universitat Magdeburg, universitatsklinikum fur Dermatologie und Venerologie
  • Klinik fur Plastiche-Asthetische- u. Handchiurgie. Kinikum Offenbach
  • HSK, Wilhelm Fresenius Klinik
  • P Stradins Clinical University Hospital
  • Regional Clinical Hospital, Partizana
  • City Clinical Hospital # 36
  • City Clinical Hospital # 36
  • Russian Medical Academy for Postgraduate Education, Surgery
  • City Clinical Hospital #13
  • The Central Clinical Hospital # 1 of LLC "Russian Railways"
  • Research Institute for Traumatology and Orthopaedy, Verhne-Volzhskaya Naberezhnaya
  • City Clinical Hospital # 7
  • Clinical Hospital n.a. N.V. Solovyov
  • Stoke Mandeville Hospital
  • Pinderfields Hospital
  • McIndoe Burns Unit, Queen Victoria Hospital
  • Selly Oak Hospital
  • Broomfield Hospital
  • Wythenshawe Hospital

Outcomes

Primary Outcome Measures

Complete wound closure of skin graft donor site.

Secondary Outcome Measures

Adverse events
Skin graft take

Full Information

First Posted
January 24, 2007
Last Updated
August 27, 2009
Sponsor
Renovo
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1. Study Identification

Unique Protocol Identification Number
NCT00426972
Brief Title
Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites
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 Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Renovo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn, Trauma, Varicose Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
estradiol (Zesteem)
Primary Outcome Measure Information:
Title
Complete wound closure of skin graft donor site.
Secondary Outcome Measure Information:
Title
Adverse events
Title
Skin graft take

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Dunn, MD
Organizational Affiliation
Wythenshawe Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitatsklinikum Aachen Klinik fur Plastiche Chirurgie
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitatsklinik fur Plastiche Chirurgie und Schwerbrandverletze
City
Bochum
ZIP/Postal Code
D-44789
Country
Germany
Facility Name
Klinik fur Dermatologie und Allergologie, Bochum St Josef Hospital
City
Bochum
ZIP/Postal Code
D-44791
Country
Germany
Facility Name
Carl- Thiem- klinikum Cottbus
City
Cottbus
ZIP/Postal Code
03048
Country
Germany
Facility Name
Abteilung fur Plastiche und Handchirurgie
City
Erlangen
ZIP/Postal Code
12, 91054
Country
Germany
Facility Name
Zentrum der Dermatologie und Venerologie, Johann Wolfgang Institut
City
Frankfurt
ZIP/Postal Code
D-D-60590
Country
Germany
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
Klinik fur Plastiche- Hand und Wiederherstellungschirurgie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Klinik fur Dermatologie, Friedrich-Schiller Universitat Jena
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Klinikum Koln-Merheim Abteilung Plastiche-, Rekonstruktive-, Asthetische- Hand- Verbrennungschirurgie
City
Koln
ZIP/Postal Code
51109
Country
Germany
Facility Name
Klinikum St. Georg- Leipzig
City
Leipzig
ZIP/Postal Code
D-04129
Country
Germany
Facility Name
Otto-von-Gericke Universitat Magdeburg, universitatsklinikum fur Dermatologie und Venerologie
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Klinik fur Plastiche-Asthetische- u. Handchiurgie. Kinikum Offenbach
City
Offenbach
ZIP/Postal Code
D-63069
Country
Germany
Facility Name
HSK, Wilhelm Fresenius Klinik
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
P Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV1002
Country
Latvia
Facility Name
Regional Clinical Hospital, Partizana
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
City Clinical Hospital # 36
City
Moscow
ZIP/Postal Code
105187
Country
Russian Federation
Facility Name
City Clinical Hospital # 36
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Russian Medical Academy for Postgraduate Education, Surgery
City
Moscow
ZIP/Postal Code
113093
Country
Russian Federation
Facility Name
City Clinical Hospital #13
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Facility Name
The Central Clinical Hospital # 1 of LLC "Russian Railways"
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Research Institute for Traumatology and Orthopaedy, Verhne-Volzhskaya Naberezhnaya
City
Novorogod
Country
Russian Federation
Facility Name
City Clinical Hospital # 7
City
Saratov
ZIP/Postal Code
410005
Country
Russian Federation
Facility Name
Clinical Hospital n.a. N.V. Solovyov
City
Yaroslavl
Country
Russian Federation
Facility Name
Stoke Mandeville Hospital
City
Aylesbury
State/Province
Buckinghamshire
ZIP/Postal Code
HP21 8AL
Country
United Kingdom
Facility Name
Pinderfields Hospital
City
Aberford Road
State/Province
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
Facility Name
McIndoe Burns Unit, Queen Victoria Hospital
City
East Grinstead
State/Province
West Sussex
ZIP/Postal Code
RH19 3DZ
Country
United Kingdom
Facility Name
Selly Oak Hospital
City
Birmingham
ZIP/Postal Code
B29 6JD
Country
United Kingdom
Facility Name
Broomfield Hospital
City
Chelmsford
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom

12. IPD Sharing Statement

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

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