Cancer Clinical Trial
Official title:
Skin Incision Study - Closure of Skin Incisions in Gynecological Cancer Surgery
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | March 2006 |
Est. primary completion date | March 2006 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Australia | QCGC, Royal Brisbane and Women's Hospital | Herston | Queensland |
Australia | Mater Adult Public Hospital | South Brisbane | Queensland |
Lead Sponsor | Collaborator |
---|---|
Queensland Centre for Gynaecological Cancer |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of the device as measured by cosmesis, pain and requirement for analgesic and antibiotic medication | 6 weeks after surgery | No | |
Secondary | 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 | No | |
Secondary | Safety of the device as expressed in the incidence of adverse events following surgery | 6 weeks after surgery | Yes |
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