Clinical trial NCT00107627: Skin Incision Study - Closure of Skin Incisions in Gynecological Cancer Surgery
Official title: Skin Incision Study - Closure of Skin Incisions in Gynecological Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Keywords: Gynaecological Cancer
Surgical Staples
Subcuticular Sutures
Lead sponsor: Queensland Centre for Gynaecological Cancer
Sponsor class: OTHER_GOV
First posted: 2005-04-07
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

* 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 methods:

* 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 trial.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of the device as measured by cosmesis, pain and requirement for analgesic and antibiotic medication
timeFrame: 6 weeks after surgery
Secondary outcomes:
measure: To evaluate the wound healing process (normal or delayed), cosmesis and pain, requirement for surgical or medical intervention (analgesic and antibiotic medication)
timeFrame: 3 months after surgery
measure: Safety of the device as expressed in the incidence of adverse events following surgery
timeFrame: 6 weeks after surgery
Other outcomes:
Locations:
city: Herston
country: Australia
facility: QCGC, Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Adult Public Hospital
state: Queensland
Study officials:
affiliation: Queensland Centre for Gynaecological Cancer
name: Andreas Obermair
role: PRINCIPAL_INVESTIGATOR
References: