Prevention of Hypertrophic Scars or Keloids (RCT)

October 19, 2012 updated by: Kuei-Chang Hsu, Kaohsiung Veterans General Hospital.

Comparison of the Effectiveness in Prevention of Hypertrophic Scars or Keloids Between Silicone Sheet, Silicone Gel and Paper Steri-strip-A Randomised Controlled Trial.

Keloids and hypertrophic scars are not major illness. However, their effects can be from causing pain and itch which substantially interfere daily activity to as severe as causing deformity and other functional impairment. For standard surgical wounds, taking median sternotomy wounds from open heart surgery and lower abdominal wounds from gynecological wounds for example, the incidence of these problems can be from 10% to 60%. To prevent or treat these problems, physicians have used many modalities. One of the most convenient, most cost-effective and most non-invasive methods for patients is using dressings like silicone sheets, silicone gels or paper tapes, which is on the list of 1st line choices of an international recommendation. According to a literature review, most of the previous studies on similar topics are either of small sample size, on non-standard wounds or comparisons between wounds on different patient groups. The methodologies of previous studies are thus not vigorous enough. To get the highest level of evidence on selecting the best dressings for preventing and treating keloids and hypertrophic scars, we will recruit about 75 patients and apply two selected dressings on each halves of their standard surgical wounds to compare their differences. The investigators hope the result of this study can help us find the best modality to use and can contribute to the welfare of our future patients.

Study Overview

Status

Status

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

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

Patients who undergo gynecological surgery with transverse lower abdominal wounds and who undergo cardiovascular surgery with median sternotomy wounds in our hospital will be assessed. Those who have or will have diabetes, chemotherapy, radiotherapy and known history of allergy to silicone will be excluded. Altogether, about 75 patients will be recruited. Each patient's wound will be divided into two halves. One test dressing will be applied to a half, which is determined by random, and a different test dressing to the other half. The total 75 patients will thus be divided into 3 groups of 25 patients. One group will act to compare the effectiveness between silicone gel and silicone sheet, the second group between silicone sheet and paper tape, and the third group between silicone gel and paper tape. The dressings will be applied one week after surgery and at least 12 hours per day until 3 months after surgery. All patients will be followed up at 4 weeks, 8 weeks, 12 weeks, 6 months and 12 months. Three domains of outcomes will be measured. One is the appearance of the scars which will be rated with Vancouver scale, which has been proved to be a reliable scale.34 35 When rating with the Vancouver scale, standardised photographs of the scars will be taken in a standardised photo studio using a single high-resolution digital camera in a standardised light condition and at a fixed distance because any difference in photographic conditions will make difference in the Vancouver scores. The other two domains are pain and itching of the scars, which will be evaluated with Visual Analog Ratings (VAR). Pain and itching are very subjective, so the rating method should be very easy to understand and applicable for our patients and that is why we chose VAR as a tool.

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 (Anticipated)

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.
75

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.
  • Not Applicable

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

  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Kaohsiung Veterans General Hospital: R.O.C.

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who undergo gynecological surgery with transverse lower abdominal wounds.
  • Patients who undergo cardiovascular surgery with median sternotomy wounds in our hospital will be assessed.

Exclusion Criteria:

  • Those who have or will have:

    • diabetes
    • chemotherapy
    • radiotherapy
  • known history of allergy to silicone will be excluded.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

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: Gel vs. Sheet
One group will act to compare the effectiveness between silicone gel and silicone sheet.
Other: silicone gel
silicone gel
Other: silicone sheet
silicone sheet
Active Comparator: sheet vs. paper tape
The second group between silicone sheet and paper tape.
Other: silicone sheet
silicone sheet
Other: paper tape
paper tape
Active Comparator: gel vs. paper tape
One group will act to compare the effectiveness between silicone gel and paper tape.
Other: silicone gel
silicone gel
Other: paper tape
paper tape

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
Scar appearance measured with Vancouver Scar Scores.
Time Frame: 12 months
12 months

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
pain and itchiness measured with Visual Analog Scales.
Time Frame: 12 months
12 months

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.
Kaohsiung Veterans General Hospital.

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: Kuei-Chang Hsu, surgeon, Department of plastic surgery in Kaohsiung Veterans General Hospital in Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2009

Primary Completion (Anticipated)

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.
December 1, 2012

Study Completion (Anticipated)

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.
December 1, 2012

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).
February 20, 2009

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.
February 20, 2009

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.
February 23, 2009

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.
October 22, 2012

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.
October 19, 2012

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.
October 1, 2012

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.
  • 97CT1018

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