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

NCT00426972 | Completed Phase 3

• 1 other identifier: RN1002-0066
• Study Type: interventional
• Target: 148
• Locations: 4 countries
• Sites: 30

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.

Conditions

Burn; Trauma; Varicose Ulcer

Outcome Measures

Primary Outcomes (1)

• Complete wound closure of skin graft donor site.

Secondary Outcomes (2)

• Adverse events

• Skin graft take

Interventions

estradiol (Zesteem) DRUG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renovo: lead

Study Sites (30)

Universitatsklinikum Aachen Klinik fur Plastiche Chirurgie

Aachen, 52074, Germany

Location

Universitatsklinik fur Plastiche Chirurgie und Schwerbrandverletze

Bochum, D-44789, Germany

Location

Klinik fur Dermatologie und Allergologie, Bochum St Josef Hospital

Bochum, D-44791, Germany

Location

Klinikum Koln-Merheim Abteilung Plastiche-, Rekonstruktive-, Asthetische- Hand- Verbrennungschirurgie

Cologne, 51109, Germany

Location

Carl- Thiem- klinikum Cottbus

Cottbus, 03048, Germany

Location

Abteilung fur Plastiche und Handchirurgie

Erlangen, 12, 91054, Germany

Location

Zentrum der Dermatologie und Venerologie, Johann Wolfgang Institut

Frankfurt, D-D-60590, Germany

Location

Universitatsklinikum Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

Klinik fur Plastiche- Hand und Wiederherstellungschirurgie

Hanover, 30625, Germany

Location

Klinik fur Dermatologie, Friedrich-Schiller Universitat Jena

Jena, 07740, Germany

Location

Klinikum St. Georg- Leipzig

Leipzig, D-04129, Germany

Location

Otto-von-Gericke Universitat Magdeburg, universitatsklinikum fur Dermatologie und Venerologie

Magdeburg, 39120, Germany

Location

Klinik fur Plastiche-Asthetische- u. Handchiurgie. Kinikum Offenbach

Offenbach, D-63069, Germany

Location

HSK, Wilhelm Fresenius Klinik

Wiesbaden, 65191, Germany

Location

P Stradins Clinical University Hospital

Riga, LV1002, Latvia

Location

Regional Clinical Hospital, Partizana

Krasnoyarsk, 660022, Russia

Location

City Clinical Hospital # 36

Moscow, 105187, Russia

Location

City Clinical Hospital # 36

Moscow, 111539, Russia

Location

Russian Medical Academy for Postgraduate Education, Surgery

Moscow, 113093, Russia

Location

City Clinical Hospital #13

Moscow, 115280, Russia

Location

The Central Clinical Hospital # 1 of LLC "Russian Railways"

Moscow, 125367, Russia

Location

Research Institute for Traumatology and Orthopaedy, Verhne-Volzhskaya Naberezhnaya

Novorogod, Russia

Location

City Clinical Hospital # 7

Saratov, 410005, Russia

Location

Clinical Hospital n.a. N.V. Solovyov

Yaroslavl, Russia

Location

Stoke Mandeville Hospital

Aylesbury, Buckinghamshire, HP21 8AL, United Kingdom

Location

Pinderfields Hospital

Aberford Road, Wakefield, WF1 4DG, United Kingdom

Location

McIndoe Burns Unit, Queen Victoria Hospital

East Grinstead, West Sussex, RH19 3DZ, United Kingdom

Location

Selly Oak Hospital

Birmingham, B29 6JD, United Kingdom

Location

Broomfield Hospital

Chelmsford, CM1 7ET, United Kingdom

Location

Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

MeSH Terms

Conditions

Burns; Wounds and Injuries; Varicose Ulcer

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ken Dunn, MD

  Wythenshawe Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 24, 2007
• First Posted: January 25, 2007
• Study Start: January 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 28, 2009

Record last verified: 2009-08

Locations

LA (1); RU (9); DE (14); GB (6)