Status:
COMPLETED
Skin Incision Study - Closure of Skin Incisions in Gynecological Cancer Surgery
Lead Sponsor:
Queensland Centre for Gynaecological Cancer
Conditions:
Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The Skin Incision Study evaluates the efficacy of skin closure methods: skin staples and subcuticular sutures at 6 weeks and at 3 months following the operation by measuring cosmesis and pain.
Detailed Description
The Surgical Skin Incisions (SSI) is an investigator initiated, randomized, prospective (pilot) study comparing methods of skin closure following gynecological cancer surgery to evaluate: * cosmesis;...
Eligibility Criteria
Inclusion
- Public patients at RBWH and at the Mater Public Hospital booked for elective surgery (laparotomy)
- Surgery for suspected or proven gynecological cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patient compliance and geographic proximity that allow adequate follow-up
- Signed written informed consent
- Females \>=18 years of age
Exclusion
- Unplanned laparotomy
- Laparoscopic procedures
- Unwillingness of the patient to participate in the trial
- Non-compliance of participant
- Unavailability for follow-up
- Patients who are unable or unwilling to give informed consent
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00107627
Start Date
March 1 2005
End Date
March 1 2006
Last Update
June 25 2009
Active Locations (2)
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1
QCGC, Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
2
Mater Adult Public Hospital
South Brisbane, Queensland, Australia, 4101