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

Tracking Information

First Received Date ^ICMJE

January 24, 2007

Last Updated Date

August 27, 2009

Start Date ^ICMJE

January 2007

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Complete wound closure of skin graft donor site.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00426972 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse events
Skin graft take

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Double Blind, Placebo Controlled Trial to Investigate the Efficacy of Zesteem (Estradiol) in Accelerating the Healing of Split Thickness Skin Graft Donor Sites.

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Burn
Trauma
Varicose Ulcer

Intervention ^ICMJE

Drug: estradiol (Zesteem)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

148

Completion Date

October 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Latvia, Russian Federation, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00426972

Responsible Party

Study ID Numbers ^ICMJE

RN1002-0066

Study Sponsor ^ICMJE

Renovo

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Ken Dunn, MD

Wythenshawe Hospital

Information Provided By

Renovo

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP