Prevention of Hypertrophic Scars or Keloids (RCT)
Primary Purpose
Hypertrophic Scars
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
silicone gel
silicone sheet
paper tape
Sponsored by
About this trial
This is an interventional prevention trial for Hypertrophic Scars focused on measuring keloid, silicone sheet, silicone gel, paper tape, steri-strip
Eligibility 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.
Sites / Locations
- Kaohsiung Veterans General Hospital: R.O.C.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Gel vs. Sheet
sheet vs. paper tape
gel vs. paper tape
Arm Description
One group will act to compare the effectiveness between silicone gel and silicone sheet.
The second group between silicone sheet and paper tape.
One group will act to compare the effectiveness between silicone gel and paper tape.
Outcomes
Primary Outcome Measures
Scar appearance measured with Vancouver Scar Scores.
Secondary Outcome Measures
pain and itchiness measured with Visual Analog Scales.
Full Information
NCT ID
NCT00849004
First Posted
February 20, 2009
Last Updated
October 19, 2012
Sponsor
Kaohsiung Veterans General Hospital.
1. Study Identification
Unique Protocol Identification Number
NCT00849004
Brief Title
Prevention of Hypertrophic Scars or Keloids
Acronym
RCT
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scars
Keywords
keloid, silicone sheet, silicone gel, paper tape, steri-strip
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gel vs. Sheet
Arm Type
Active Comparator
Arm Description
One group will act to compare the effectiveness between silicone gel and silicone sheet.
Arm Title
sheet vs. paper tape
Arm Type
Active Comparator
Arm Description
The second group between silicone sheet and paper tape.
Arm Title
gel vs. paper tape
Arm Type
Active Comparator
Arm Description
One group will act to compare the effectiveness between silicone gel and paper tape.
Intervention Type
Other
Intervention Name(s)
silicone gel
Intervention Description
silicone gel
Intervention Type
Other
Intervention Name(s)
silicone sheet
Intervention Description
silicone sheet
Intervention Type
Other
Intervention Name(s)
paper tape
Intervention Description
paper tape
Primary Outcome Measure Information:
Title
Scar appearance measured with Vancouver Scar Scores.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
pain and itchiness measured with Visual Analog Scales.
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuei-Chang Hsu, surgeon
Organizational Affiliation
Department of plastic surgery in Kaohsiung Veterans General Hospital in Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital: R.O.C.
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
12. IPD Sharing Statement
Citations:
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Prevention of Hypertrophic Scars or Keloids
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