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Prevention of Hypertrophic Scars or Keloids (RCT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Kaohsiung Veterans General Hospital..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Kuei-Chang Hsu, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT00849004
First received: February 20, 2009
Last updated: October 19, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Hypertrophic Scars
Other: silicone gel
Other: silicone sheet
Other: paper tape

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of the Effectiveness in Prevention of Hypertrophic Scars or Keloids Between Silicone Sheet, Silicone Gel and Paper Steri-strip-A Randomised Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • Scar appearance measured with Vancouver Scar Scores. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain and itchiness measured with Visual Analog Scales. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: March 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849004

Locations
Taiwan
Kaohsiung Veterans General Hospital: R.O.C.
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
Principal Investigator: Kuei-Chang Hsu, surgeon Department of plastic surgery in Kaohsiung Veterans General Hospital in Taiwan
  More Information

Publications:

Responsible Party: Kuei-Chang Hsu, Consultant Surgeon, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT00849004     History of Changes
Other Study ID Numbers: 97CT1018, 97CT1018
Study First Received: February 20, 2009
Last Updated: October 19, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Veterans General Hospital.:
keloid
silicone sheet
silicone gel
paper tape
steri-strip

Additional relevant MeSH terms:
Cicatrix, Hypertrophic
Hypertrophy
Cicatrix
Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 24, 2014