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

Sponsor
Renovo (Industry)
Overall Status
Completed
CT.gov ID
NCT00426972
Collaborator
(none)
148
Enrollment
30
Locations
21
Duration (Months)
4.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: estradiol (Zesteem)
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
148 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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.
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Oct 1, 2008

Outcome Measures

Primary Outcome Measures

  1. Complete wound closure of skin graft donor site. []

Secondary Outcome Measures

  1. Adverse events []

  2. Skin graft take []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

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

Sponsors and Collaborators

  • Renovo

Investigators

  • Principal Investigator: Ken Dunn, MD, Wythenshawe Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00426972
Other Study ID Numbers:
  • RN1002-0066
First Posted:
Jan 25, 2007
Last Update Posted:
Aug 28, 2009
Last Verified:
Aug 1, 2009
Additional relevant MeSH terms:
Varicose Ulcer
Estradiol

Study Results

No Results Posted as of Aug 28, 2009