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

June 24, 2009 updated by: Queensland Centre for Gynaecological Cancer
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4029
        • QCGC, Royal Brisbane and Women's Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Mater Adult Public Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Skin staples;
Other: Skin staples;
Skin staples;
Other Names:
  • Staples
Active Comparator: 2
Monocryl subcuticular sutures.
Other: Monocryl subcuticular sutures.
Monocryl subcuticular sutures.
Other Names:
  • Stitches
  • Sutures,
Active Comparator: 3
Caprosyn subcuticular sutures.
Other: Caprosyn subcuticular sutures.
Caprosyn subcuticular sutures.
Other Names:
  • Sutures
  • Stitches

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of the device as measured by cosmesis, pain and requirement for analgesic and antibiotic medication
Time Frame: 6 weeks after surgery
6 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months after surgery
Safety of the device as expressed in the incidence of adverse events following surgery
Time Frame: 6 weeks after surgery
6 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queensland Centre for Gynaecological Cancer

Investigators

  • Principal Investigator: Andreas Obermair, Queensland Centre for Gynaecological Cancer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

April 6, 2005

First Submitted That Met QC Criteria

April 6, 2005

First Posted (Estimate)

April 7, 2005

Study Record Updates

Last Update Posted (Estimate)

June 25, 2009

Last Update Submitted That Met QC Criteria

June 24, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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