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

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

Interventional

Enrollment (Anticipated)

75

Phase

  • 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

      • 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

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Investigators

  • 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

March 1, 2009

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

February 20, 2009

First Submitted That Met QC Criteria

February 20, 2009

First Posted (Estimate)

February 23, 2009

Study Record Updates

Last Update Posted (Estimate)

October 22, 2012

Last Update Submitted That Met QC Criteria

October 19, 2012

Last Verified

October 1, 2012

More Information

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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