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

This study has been completed.
Sponsor:
Information provided by:
Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier:
NCT00107627
First received: April 6, 2005
Last updated: June 24, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Cancer
Other: Caprosyn subcuticular sutures.
Other: Monocryl subcuticular sutures.
Other: Skin staples;
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Skin Incision Study - Closure of Skin Incisions in Gynecological Cancer Surgery

Resource links provided by NLM:


Further study details as provided by Queensland Centre for Gynaecological Cancer:

Primary Outcome Measures:
  • Efficacy of the device as measured by cosmesis, pain and requirement for analgesic and antibiotic medication [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the wound healing process (normal or delayed), cosmesis and pain, requirement for surgical or medical intervention (analgesic and antibiotic medication) [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
  • Safety of the device as expressed in the incidence of adverse events following surgery [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: March 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Skin staples;
Other: Skin staples;
Skin staples;
Other Name: Staples
Active Comparator: 2
Monocryl subcuticular sutures.
Other: Monocryl subcuticular sutures.
Monocryl subcuticular sutures.
Other Names:
  • Sutures,
  • Stitches
Active Comparator: 3
Caprosyn subcuticular sutures.
Other: Caprosyn subcuticular sutures.
Caprosyn subcuticular sutures.
Other Names:
  • Sutures
  • Stitches

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107627

Locations
Australia, Queensland
QCGC, Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Mater Adult Public Hospital
South Brisbane, Queensland, Australia, 4101
Sponsors and Collaborators
Queensland Centre for Gynaecological Cancer
Investigators
Principal Investigator: Andreas Obermair Queensland Centre for Gynaecological Cancer
  More Information

No publications provided

Responsible Party: Professor Andreas Obermair, Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier: NCT00107627     History of Changes
Other Study ID Numbers: SIS001
Study First Received: April 6, 2005
Last Updated: June 24, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Queensland Centre for Gynaecological Cancer:
Gynaecological Cancer
Surgical Staples
Subcuticular Sutures

ClinicalTrials.gov processed this record on July 31, 2014