Skin Incision Study - Closure of Skin Incisions in Gynecological Cancer Surgery
1 other identifier
interventional
90
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 cancer
Started Mar 2005
Shorter than P25 for phase_3 cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 6, 2005
CompletedFirst Posted
Study publicly available on registry
April 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedJune 25, 2009
June 1, 2009
1 year
April 6, 2005
June 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of the device as measured by cosmesis, pain and requirement for analgesic and antibiotic medication
6 weeks after surgery
Secondary Outcomes (2)
To evaluate the wound healing process (normal or delayed), cosmesis and pain, requirement for surgical or medical intervention (analgesic and antibiotic medication)
3 months after surgery
Safety of the device as expressed in the incidence of adverse events following surgery
6 weeks after surgery
Study Arms (3)
1
ACTIVE COMPARATORSkin staples;
2
ACTIVE COMPARATORMonocryl subcuticular sutures.
3
ACTIVE COMPARATORCaprosyn subcuticular sutures.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
QCGC, Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Mater Adult Public Hospital
South Brisbane, Queensland, 4101, Australia
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Obermair
Queensland Centre for Gynaecological Cancer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
April 6, 2005
First Posted
April 7, 2005
Study Start
March 1, 2005
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
June 25, 2009
Record last verified: 2009-06