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

Phase 3

Completed

• Conditions: Burn; Trauma; Varicose Ulcer

• Registration Number: NCT00426972
• Lead Sponsor: Renovo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-24
• Study First Submitted QC: 2007-01-24
• Study First Posted: 2007-01-25
• Primary Completion: 2008-07
• Study Completion: 2008-10
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-27
• Last Update Posted: 2009-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complete wound closure of skin graft donor site.

Secondary Outcome Measures

Name	Time	Method
Adverse events
Skin graft take

Trial Locations

Locations (29)

Stoke Mandeville Hospital; 🇬🇧 Aylesbury, Buckinghamshire, United Kingdom

Selly Oak Hospital; 🇬🇧 Birmingham, United Kingdom

City Clinical Hospital #13; 🇷🇺 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, Russian Federation

Regional Clinical Hospital, Partizana; 🇷🇺 Krasnoyarsk, Russian Federation

McIndoe Burns Unit, Queen Victoria Hospital; 🇬🇧 East Grinstead, West Sussex, United Kingdom

City Clinical Hospital # 36; 🇷🇺 Moscow, Russian Federation

Broomfield Hospital; 🇬🇧 Chelmsford, United Kingdom

The Central Clinical Hospital # 1 of LLC "Russian Railways"; 🇷🇺 Moscow, Russian Federation

Russian Medical Academy for Postgraduate Education, Surgery; 🇷🇺 Moscow, Russian Federation

Wythenshawe Hospital; 🇬🇧 Manchester, United Kingdom

Universitatsklinik fur Plastiche Chirurgie und Schwerbrandverletze; 🇩🇪 Bochum, Germany

Zentrum der Dermatologie und Venerologie, Johann Wolfgang Institut; 🇩🇪 Frankfurt, Germany

Klinikum St. Georg- Leipzig; 🇩🇪 Leipzig, Germany

Klinikum Koln-Merheim Abteilung Plastiche-, Rekonstruktive-, Asthetische- Hand- Verbrennungschirurgie; 🇩🇪 Koln, Germany

HSK, Wilhelm Fresenius Klinik; 🇩🇪 Wiesbaden, Germany

P Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

Pinderfields Hospital; 🇬🇧 Aberford Road, Wakefield, United Kingdom

Otto-von-Gericke Universitat Magdeburg, universitatsklinikum fur Dermatologie und Venerologie; 🇩🇪 Magdeburg, Germany

Carl- Thiem- klinikum Cottbus; 🇩🇪 Cottbus, Germany

Abteilung fur Plastiche und Handchirurgie; 🇩🇪 Erlangen, Germany

Universitatsklinikum Aachen Klinik fur Plastiche Chirurgie; 🇩🇪 Aachen, Germany

Klinik fur Dermatologie und Allergologie, Bochum St Josef Hospital; 🇩🇪 Bochum, Germany

Klinik fur Dermatologie, Friedrich-Schiller Universitat Jena; 🇩🇪 Jena, Germany

Klinik fur Plastiche-Asthetische- u. Handchiurgie. Kinikum Offenbach; 🇩🇪 Offenbach, Germany

Universitatsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Klinik fur Plastiche- Hand und Wiederherstellungschirurgie; 🇩🇪 Hannover, Germany