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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00107627




Registration number
NCT00107627
Ethics application status
Date submitted
6/04/2005
Date registered
7/04/2005
Date last updated
25/06/2009

Titles & IDs
Public title
Skin Incision Study - Closure of Skin Incisions in Gynecological Cancer Surgery
Scientific title
Skin Incision Study - Closure of Skin Incisions in Gynecological Cancer Surgery
Secondary ID [1] 0 0
SIS001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code
Surgery 0 0 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Caprosyn subcuticular sutures.
Other interventions - Monocryl subcuticular sutures.
Other interventions - Skin staples;

Active comparator: 1 - Skin staples;

Active comparator: 2 - Monocryl subcuticular sutures.

Active comparator: 3 - Caprosyn subcuticular sutures.


Other interventions: Caprosyn subcuticular sutures.
Caprosyn subcuticular sutures.

Other interventions: Monocryl subcuticular sutures.
Monocryl subcuticular sutures.

Other interventions: Skin staples;
Skin staples;
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy of the device as measured by cosmesis, pain and requirement for analgesic and antibiotic medication
Timepoint [1] 0 0
6 weeks after surgery
Secondary outcome [1] 0 0
To evaluate the wound healing process (normal or delayed), cosmesis and pain, requirement for surgical or medical intervention (analgesic and antibiotic medication)
Timepoint [1] 0 0
3 months after surgery
Secondary outcome [2] 0 0
Safety of the device as expressed in the incidence of adverse events following surgery
Timepoint [2] 0 0
6 weeks after surgery

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2006
Sample size
Target
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
QCGC, Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [2] 0 0
Mater Adult Public Hospital - South Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane

Funding & Sponsors
Primary sponsor type
Government body
Name
Queensland Centre for Gynaecological Cancer
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00107627
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andreas Obermair
Address 0 0
Queensland Centre for Gynaecological Cancer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00107627