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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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

Study type
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

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

Key inclusion criteria
- Public patients at RBWH and at the Mater Public Hospital booked for elective surgery

- 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
Can healthy volunteers participate?
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
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Queensland Centre for Gynaecological Cancer

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

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 data has been provided for results reporting
Summary results
Other publications