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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00107627