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

Trauma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426972
• Other study ID #: RN1002-0066
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2007
• Last updated: August 27, 2009
• Start date: January 2007
• Est. completion date: October 2008

Study information

• Verified date: August 2009
• Source: Renovo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Latvia: State Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: October 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burn
• Trauma
• Varicose Ulcer

Intervention

Drug:
• estradiol (Zesteem)

Locations

Country	Name	City	State
Germany	Universitatsklinikum Aachen Klinik fur Plastiche Chirurgie	Aachen
Germany	Klinik fur Dermatologie und Allergologie, Bochum St Josef Hospital	Bochum
Germany	Universitatsklinik fur Plastiche Chirurgie und Schwerbrandverletze	Bochum
Germany	Carl- Thiem- klinikum Cottbus	Cottbus
Germany	Abteilung fur Plastiche und Handchirurgie	Erlangen
Germany	Zentrum der Dermatologie und Venerologie, Johann Wolfgang Institut	Frankfurt
Germany	Universitatsklinikum Freiburg	Freiburg
Germany	Klinik fur Plastiche- Hand und Wiederherstellungschirurgie	Hannover
Germany	Klinik fur Dermatologie, Friedrich-Schiller Universitat Jena	Jena
Germany	Klinikum Koln-Merheim Abteilung Plastiche-, Rekonstruktive-, Asthetische- Hand- Verbrennungschirurgie	Koln
Germany	Klinikum St. Georg- Leipzig	Leipzig
Germany	Otto-von-Gericke Universitat Magdeburg, universitatsklinikum fur Dermatologie und Venerologie	Magdeburg
Germany	Klinik fur Plastiche-Asthetische- u. Handchiurgie. Kinikum Offenbach	Offenbach
Germany	HSK, Wilhelm Fresenius Klinik	Wiesbaden
Latvia	P Stradins Clinical University Hospital	Riga
Russian Federation	Regional Clinical Hospital, Partizana	Krasnoyarsk
Russian Federation	City Clinical Hospital # 36	Moscow
Russian Federation	City Clinical Hospital # 36	Moscow
Russian Federation	City Clinical Hospital #13	Moscow
Russian Federation	Russian Medical Academy for Postgraduate Education, Surgery	Moscow
Russian Federation	The Central Clinical Hospital # 1 of LLC "Russian Railways"	Moscow
Russian Federation	Research Institute for Traumatology and Orthopaedy, Verhne-Volzhskaya Naberezhnaya	Novorogod
Russian Federation	City Clinical Hospital # 7	Saratov
Russian Federation	Clinical Hospital n.a. N.V. Solovyov	Yaroslavl
United Kingdom	Pinderfields Hospital	Aberford Road	Wakefield
United Kingdom	Stoke Mandeville Hospital	Aylesbury	Buckinghamshire
United Kingdom	Selly Oak Hospital	Birmingham
United Kingdom	Broomfield Hospital	Chelmsford
United Kingdom	McIndoe Burns Unit, Queen Victoria Hospital	East Grinstead	West Sussex
United Kingdom	Wythenshawe Hospital	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Renovo

Countries where clinical trial is conducted

Germany,  Latvia,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete wound closure of skin graft donor site.
Secondary	Adverse events
Secondary	Skin graft take