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Skin Incision Study - Closure of Skin Incisions in Gynecological Cancer Surgery

Phase 3
18 Years
Not Enrolling

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Trial Information

Skin Incision Study - Closure of Skin Incisions in Gynecological Cancer Surgery

The Surgical Skin Incisions (SSI) is an investigator initiated, randomized, prospective
(pilot) study comparing methods of skin closure following gynecological cancer surgery to

- cosmesis;

- pain;

- adverse events.

The two most common methods of skin incision closure are staples or subcuticular sutures.
Adverse events to surgical incisions represent major and significant burdens to patients and
the health care system; however, no data is available comparing methods of skin closure.
Surgeons have traditionally had to use personal belief rather than data or evidence to
choose the method of skin incision closure. This study evaluates three types of skin closure

- Skin staples;

- Monocryl subcuticular sutures;

- Caprosyn subcuticular sutures.

The objective of this trial is to evaluate the efficacy of sutures and staples at 6 weeks
and at 3 months following the operation by measuring cosmesis and pain. These are assessed
by both the patient and the surgeon independently using linear analogue scales and by
collecting information on analgesic medications taken by the patient. The safety of the
staples and sutures will be expressed by the incidence of adverse events following surgery.
Post-operative events such as wound infection, other wound complications, grade of
inflammation, hemorrhage and other complications will be graded according to the Common
Toxicity Criteria (CTC version 3) and recorded.

Investigators will invite public patients with proven or suspected gynecological cancer from
Royal Brisbane and Women's Hospital and Mater Hospital (RBWH) that are booked to have
elective surgery and that meet the selection criteria to participate in this study.

This is a pilot study to generate data for a definitive randomized study. Ninety (90)
patients are required for recruitment to the pilot study.

The type of closure method patients will receive will be allocated using a randomization
process. Three equally sized study arms of 30 patients will have their surgical incision
closed with either surgical staples, Monocryl or Caprosyn. Additionally, patients will be
stratified by site so as to remove selection bias.

All tests and assessments before and after the operation are standard of care. These results
will be recorded. No additional tests or assessments will be performed for the aim of this

Randomization, data management and statistical analysis will be coordinated by the
Queensland Centre for Gynaecological Cancer. Statistical analysis will include calculating
mean values and standard deviations for scores for each group at each assessment. Chi-square
tests will be used to compare differences in proportions of patients who did or did not
experience adverse events at each time point.

Results of this trial will be presented at scientific meetings at a national and
international level and at educational meetings with medical staff. The results of this
trial will also be submitted for publishing. The study will generate data for a definitive
randomized study.

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Efficacy of the device as measured by cosmesis, pain and requirement for analgesic and antibiotic medication

Outcome Time Frame:

6 weeks after surgery

Safety Issue:


Principal Investigator

Andreas Obermair

Investigator Role:

Principal Investigator

Investigator Affiliation:

Queensland Centre for Gynaecological Cancer


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

March 2005

Completion Date:

March 2006

Related Keywords:

  • Cancer
  • Gynaecological Cancer
  • Surgical Staples
  • Subcuticular Sutures