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CompletedNCT00426972Updated Aug 28, 2009

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

A Phase 3 interventional study of estradiol (Zesteem) in Burn, Trauma and Varicose Ulcer, sponsored by Renovo. Completed at 30 sites in 4 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2009-08-28.

Sponsored by Renovo · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Burn
  • Trauma
  • Varicose Ulcer

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03

In context

Varicose Ulcer

378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.

This study's planned enrollment of 148 is above the median of 64 across 325 interventional studies indexed under Varicose Ulcer.

Browse Varicose Ulcer studies →

Lead sponsor

Renovo is the lead sponsor of 30 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
148 participants (estimated)

Interventions

  • Drugestradiol (Zesteem)
06

What researchers measure

Primary outcomes

  1. Complete wound closure of skin graft donor site.

Secondary outcomes

  1. Adverse events

  2. Skin graft take

07

Study locations

30 sites
  • Universitatsklinikum Aachen Klinik fur Plastiche Chirurgie
    Aachen, 52074, Germany
  • Universitatsklinik fur Plastiche Chirurgie und Schwerbrandverletze
    Bochum, D-44789, Germany
  • Klinik fur Dermatologie und Allergologie, Bochum St Josef Hospital
    Bochum, D-44791, Germany
  • Carl- Thiem- klinikum Cottbus
    Cottbus, 03048, Germany
  • Abteilung fur Plastiche und Handchirurgie
    Erlangen, 12, 91054, Germany
  • Zentrum der Dermatologie und Venerologie, Johann Wolfgang Institut
    Frankfurt, D-D-60590, Germany
  • Universitatsklinikum Freiburg
    Freiburg, D-79106, Germany
  • Klinik fur Plastiche- Hand und Wiederherstellungschirurgie
    Hannover, 30625, Germany
  • Klinik fur Dermatologie, Friedrich-Schiller Universitat Jena
    Jena, 07740, Germany
  • Klinikum Koln-Merheim Abteilung Plastiche-, Rekonstruktive-, Asthetische- Hand- Verbrennungschirurgie
    Koln, 51109, Germany
  • Klinikum St. Georg- Leipzig
    Leipzig, D-04129, Germany
  • Otto-von-Gericke Universitat Magdeburg, universitatsklinikum fur Dermatologie und Venerologie
    Magdeburg, 39120, Germany
  • Klinik fur Plastiche-Asthetische- u. Handchiurgie. Kinikum Offenbach
    Offenbach, D-63069, Germany
  • HSK, Wilhelm Fresenius Klinik
    Wiesbaden, 65191, Germany
  • P Stradins Clinical University Hospital
    Riga, LV1002, Latvia
  • Regional Clinical Hospital, Partizana
    Krasnoyarsk, 660022, Russian Federation
  • City Clinical Hospital # 36
    Moscow, 105187, Russian Federation
  • City Clinical Hospital # 36
    Moscow, 111539, Russian Federation
  • Russian Medical Academy for Postgraduate Education, Surgery
    Moscow, 113093, Russian Federation
  • City Clinical Hospital #13
    Moscow, 115280, Russian Federation
  • The Central Clinical Hospital # 1 of LLC "Russian Railways"
    Moscow, 125367, Russian Federation
  • Research Institute for Traumatology and Orthopaedy, Verhne-Volzhskaya Naberezhnaya
    Novorogod, Russian Federation
  • City Clinical Hospital # 7
    Saratov, 410005, Russian Federation
  • Clinical Hospital n.a. N.V. Solovyov
    Yaroslavl, Russian Federation
  • Stoke Mandeville Hospital
    Aylesbury, Buckinghamshire HP21 8AL, United Kingdom
  • Pinderfields Hospital
    Aberford Road, Wakefield WF1 4DG, United Kingdom
  • McIndoe Burns Unit, Queen Victoria Hospital
    East Grinstead, West Sussex RH19 3DZ, United Kingdom
  • Selly Oak Hospital
    Birmingham, B29 6JD, United Kingdom
  • Broomfield Hospital
    Chelmsford, CM1 7ET, United Kingdom
  • Wythenshawe Hospital
    Manchester, M23 9LT, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00426972
Lead sponsor
Renovo
First posted
Jan 25, 2007
Start date
Jan 2007
Primary completion
Jul 2008
Completion
Oct 2008
Last update
Aug 28, 2009

Study contacts

Ken Dunn, MD
principal investigator · Wythenshawe Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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