Clinical trial NCT00426972: Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Burn
Trauma
Varicose Ulcer
Lead sponsor: Renovo
Sponsor class: INDUSTRY
First posted: 2007-01-25
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Complete wound closure of skin graft donor site.
Secondary outcomes:
measure: Adverse events
measure: Skin graft take
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitatsklinikum Aachen Klinik fur Plastiche Chirurgie
city: Bochum
country: Germany
facility: Universitatsklinik fur Plastiche Chirurgie und Schwerbrandverletze
city: Bochum
country: Germany
facility: Klinik fur Dermatologie und Allergologie, Bochum St Josef Hospital
city: Cottbus
country: Germany
facility: Carl- Thiem- klinikum Cottbus
city: Erlangen
country: Germany
facility: Abteilung fur Plastiche und Handchirurgie
city: Frankfurt
country: Germany
facility: Zentrum der Dermatologie und Venerologie, Johann Wolfgang Institut
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Hannover
country: Germany
facility: Klinik fur Plastiche- Hand und Wiederherstellungschirurgie
city: Jena
country: Germany
facility: Klinik fur Dermatologie, Friedrich-Schiller Universitat Jena
city: Koln
country: Germany
facility: Klinikum Koln-Merheim Abteilung Plastiche-, Rekonstruktive-, Asthetische- Hand- Verbrennungschirurgie
city: Leipzig
country: Germany
facility: Klinikum St. Georg- Leipzig
city: Magdeburg
country: Germany
facility: Otto-von-Gericke Universitat Magdeburg, universitatsklinikum fur Dermatologie und Venerologie
city: Offenbach
country: Germany
facility: Klinik fur Plastiche-Asthetische- u. Handchiurgie. Kinikum Offenbach
city: Wiesbaden
country: Germany
facility: HSK, Wilhelm Fresenius Klinik
city: Riga
country: Latvia
facility: P Stradins Clinical University Hospital
city: Krasnoyarsk
country: Russian Federation
facility: Regional Clinical Hospital, Partizana
city: Moscow
country: Russian Federation
facility: City Clinical Hospital # 36
city: Moscow
country: Russian Federation
facility: City Clinical Hospital # 36
city: Moscow
country: Russian Federation
facility: Russian Medical Academy for Postgraduate Education, Surgery
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #13
city: Moscow
country: Russian Federation
facility: The Central Clinical Hospital # 1 of LLC "Russian Railways"
city: Novorogod
country: Russian Federation
facility: Research Institute for Traumatology and Orthopaedy, Verhne-Volzhskaya Naberezhnaya
city: Saratov
country: Russian Federation
facility: City Clinical Hospital # 7
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital n.a. N.V. Solovyov
city: Aylesbury
country: United Kingdom
facility: Stoke Mandeville Hospital
state: Buckinghamshire
city: Aberford Road
country: United Kingdom
facility: Pinderfields Hospital
state: Wakefield
city: East Grinstead
country: United Kingdom
facility: McIndoe Burns Unit, Queen Victoria Hospital
state: West Sussex
city: Birmingham
country: United Kingdom
facility: Selly Oak Hospital
city: Chelmsford
country: United Kingdom
facility: Broomfield Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
Study officials:
affiliation: Wythenshawe Hospital
name: Ken Dunn, MD
role: PRINCIPAL_INVESTIGATOR
References: