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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Queensland Centre for Gynaecological Cancer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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