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

NCT ID: NCT00107627

Last Updated: 2009-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2006-03-31

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

1

Skin staples;

Group Type: ACTIVE_COMPARATOR

Skin staples;

Intervention Type: OTHER

Skin staples;

2

Monocryl subcuticular sutures.

Group Type: ACTIVE_COMPARATOR

Monocryl subcuticular sutures.

Intervention Type: OTHER

Monocryl subcuticular sutures.

3

Caprosyn subcuticular sutures.

Group Type: ACTIVE_COMPARATOR

Caprosyn subcuticular sutures.

Intervention Type: OTHER

Caprosyn subcuticular sutures.

Interventions

Caprosyn subcuticular sutures.

Caprosyn subcuticular sutures.

Intervention Type: OTHER

Monocryl subcuticular sutures.

Monocryl subcuticular sutures.

Intervention Type: OTHER

Skin staples;

Skin staples;

Intervention Type: OTHER

Other Intervention Names

Sutures; Stitches; Sutures,; Stitches; Staples

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Queensland Centre for Gynaecological Cancer

OTHER_GOV

Sponsor Role: lead

Responsible Party

Queensland Centre for Gynaecological Cancer

Principal Investigators

Andreas Obermair

Role: PRINCIPAL_INVESTIGATOR

Queensland Centre for Gynaecological Cancer

Locations

QCGC, Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Mater Adult Public Hospital

South Brisbane, Queensland, Australia

Countries

Australia

Other Identifiers

SIS001

Identifier Type: -

Identifier Source: org_study_id