Hypertrophic ScarsRCTNCT00849004
Prevention of Hypertrophic Scars or Keloids
A study testing silicone gel, silicone sheet and paper tape in people with Hypertrophic Scars, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertrophic Scars
- What is being tested?
- silicone gel, silicone sheet and paper tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Those who have or will have:
- diabetes
- chemotherapy
- radiotherapy
- known history of allergy to silicone will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Hypertrophic Scars
- Being tested
- silicone gel, silicone sheet, paper tape
- Keywords
- keloid, silicone sheet, silicone gel, paper tape, steri-strip
- Medical subject headings
- Cicatrix, Hypertrophic, Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silicone gelOther
silicone gel
silicone sheetOther
silicone sheet
paper tapeOther
paper tape
| Study group | Role | What they receive |
|---|---|---|
| Gel vs. Sheet | Active comparator | One group will act to compare the effectiveness between silicone gel and silicone sheet. Receives: Other: silicone gel; Other: silicone sheet |
| sheet vs. paper tape | Active comparator | The second group between silicone sheet and paper tape. Receives: Other: silicone sheet; Other: paper tape |
| gel vs. paper tape | Active comparator | One group will act to compare the effectiveness between silicone gel and paper tape. Receives: Other: silicone gel; Other: paper tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar appearance measured with Vancouver Scar Scores.
Measured: 12 months
Secondary outcomes (1)
pain and itchiness measured with Visual Analog Scales.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuei-Chang Hsu, Kaohsiung Veterans General Hospital.
- Investigators
- Kuei-Chang Hsu, surgeon, Principal investigator, Department of plastic surgery in Kaohsiung Veterans General Hospital in Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849004
- Sponsor's protocol ID
- 97CT1018
- Other IDs
- 97CT1018
- Acronym
- RCT
- Status last verified
- Oct 2012
- First submitted
- 20 Feb 2009
- Last updated
- 22 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pellard S. Epidemiology, aetiology and management of abnormal scarring: a review of the literature. J Wound Care. 2006 Jan;15(1):44-8. doi: 10.12968/jowc.2006.15.1.26863.
PubMed 16669306Murison M, James W. Preliminary evaluation of the efficacy of dermatix silicone gel in the reduction of scar elevation and pigmentation. J Plast Reconstr Aesthet Surg. 2006;59(4):437-9. doi: 10.1016/j.bjps.2005.09.037. No abstract available.
PubMed 16756266Rayner K. The use of pressure therapy to treat hypertrophic scarring. J Wound Care. 2000 Mar;9(3):151-3. No abstract available.
PubMed 11933297Mustoe TA. Scars and keloids. BMJ. 2004 Jun 5;328(7452):1329-30. doi: 10.1136/bmj.328.7452.1329. No abstract available.
PubMed 15178589Baryza MJ, Baryza GA. The Vancouver Scar Scale: an administration tool and its interrater reliability. J Burn Care Rehabil. 1995 Sep-Oct;16(5):535-8. doi: 10.1097/00004630-199509000-00013.
PubMed 8537427Wu WS, Wang FS, Yang KD, Huang CC, Kuo YR. Dexamethasone induction of keloid regression through effective suppression of VEGF expression and keloid fibroblast proliferation. J Invest Dermatol. 2006 Jun;126(6):1264-71. doi: 10.1038/sj.jid.5700274.
PubMed 16575391Giovannini UM. Treatment of scars by steroid injections. Wound Repair Regen. 2002 Mar-Apr;10(2):116-7. doi: 10.1046/j.1524-475x.2002.00206.x. No abstract available.
PubMed 12028527Chuangsuwanich A, Osathalert V, Muangsombut S. Self-adhesive silicone gel sheet: a treatment for hypertrophic scars and keloids. J Med Assoc Thai. 2000 Apr;83(4):439-44.
PubMed 10808705Suetak T, Sasai S, Zhen YX, Tagami H. Effects of silicone gel sheet on the stratum corneum hydration. Br J Plast Surg. 2000 Sep;53(6):503-7. doi: 10.1054/bjps.2000.3388.
PubMed 10927682Borgognoni L. Biological effects of silicone gel sheeting. Wound Repair Regen. 2002 Mar-Apr;10(2):118-21. doi: 10.1046/j.1524-475x.2002.00205.x. No abstract available.
PubMed 12028528Musgrave MA, Umraw N, Fish JS, Gomez M, Cartotto RC. The effect of silicone gel sheets on perfusion of hypertrophic burn scars. J Burn Care Rehabil. 2002 May-Jun;23(3):208-14. doi: 10.1097/00004630-200205000-00010.
PubMed 12032371Quinn KJ. Silicone gel in scar treatment. Burns Incl Therm Inj. 1987 Oct;13 Suppl:S33-40. doi: 10.1016/0305-4179(87)90091-x. No abstract available.
PubMed 3690373Ahn ST, Monafo WW, Mustoe TA. Topical silicone gel for the prevention and treatment of hypertrophic scar. Arch Surg. 1991 Apr;126(4):499-504. doi: 10.1001/archsurg.1991.01410280103016.
PubMed 2009067Katz BE. Silicone gel sheeting in scar therapy. Cutis. 1995 Jul;56(1):65-7.
PubMed 7555106Niessen FB, Spauwen PH, Robinson PH, Fidler V, Kon M. The use of silicone occlusive sheeting (Sil-K) and silicone occlusive gel (Epiderm) in the prevention of hypertrophic scar formation. Plast Reconstr Surg. 1998 Nov;102(6):1962-72. doi: 10.1097/00006534-199811000-00023.
PubMed 9810992
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00849004
- Acronym / sponsor ID
- RCT / 97CT1018
- Conditions
- Hypertrophic Scars
- Keywords
- keloid, silicone sheet, silicone gel, paper tape, steri-strip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 23 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gel vs. Sheet | Active comparator | Other: silicone gel, Other: silicone sheetOne group will act to compare the effectiveness between silicone gel and silicone sheet. |
| sheet vs. paper tape | Active comparator | Other: silicone sheet, Other: paper tapeThe second group between silicone sheet and paper tape. |
| gel vs. paper tape | Active comparator | Other: silicone gel, Other: paper tapeOne group will act to compare the effectiveness between silicone gel and paper tape. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- Those who have or will have:
- known history of allergy to silicone will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| silicone gelsilicone gel | Other | Gel vs. Sheet, gel vs. paper tape |
| silicone sheetsilicone sheet | Other | Gel vs. Sheet, sheet vs. paper tape |
| paper tapepaper tape | Other | gel vs. paper tape, sheet vs. paper tape |
Primary outcome
Scar appearance measured with Vancouver Scar Scores.
Time frame: 12 months
1 secondary outcome
pain and itchiness measured with Visual Analog Scales.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2012.
- Background: PubMed 16669306Pellard S. Epidemiology, aetiology and management of abnormal scarring: a review of the literature. J Wound Care. 2006 Jan;15(1):44-8. doi: 10.12968/jowc.2006.15.1.26863.
- Background: PubMed 16756266Murison M, James W. Preliminary evaluation of the efficacy of dermatix silicone gel in the reduction of scar elevation and pigmentation. J Plast Reconstr Aesthet Surg. 2006;59(4):437-9. doi: 10.1016/j.bjps.2005.09.037. No abstract available.
- Background: PubMed 11933297Rayner K. The use of pressure therapy to treat hypertrophic scarring. J Wound Care. 2000 Mar;9(3):151-3. No abstract available.
- Background: PubMed 15178589Mustoe TA. Scars and keloids. BMJ. 2004 Jun 5;328(7452):1329-30. doi: 10.1136/bmj.328.7452.1329. No abstract available.
- Background: PubMed 8537427Baryza MJ, Baryza GA. The Vancouver Scar Scale: an administration tool and its interrater reliability. J Burn Care Rehabil. 1995 Sep-Oct;16(5):535-8. doi: 10.1097/00004630-199509000-00013.
- Results publication: PubMed 16575391Wu WS, Wang FS, Yang KD, Huang CC, Kuo YR. Dexamethasone induction of keloid regression through effective suppression of VEGF expression and keloid fibroblast proliferation. J Invest Dermatol. 2006 Jun;126(6):1264-71. doi: 10.1038/sj.jid.5700274.
- Results publication: PubMed 12028527Giovannini UM. Treatment of scars by steroid injections. Wound Repair Regen. 2002 Mar-Apr;10(2):116-7. doi: 10.1046/j.1524-475x.2002.00206.x. No abstract available.
- Results publication: PubMed 10808705Chuangsuwanich A, Osathalert V, Muangsombut S. Self-adhesive silicone gel sheet: a treatment for hypertrophic scars and keloids. J Med Assoc Thai. 2000 Apr;83(4):439-44.
- Results publication: PubMed 10927682Suetak T, Sasai S, Zhen YX, Tagami H. Effects of silicone gel sheet on the stratum corneum hydration. Br J Plast Surg. 2000 Sep;53(6):503-7. doi: 10.1054/bjps.2000.3388.
- Results publication: PubMed 12028528Borgognoni L. Biological effects of silicone gel sheeting. Wound Repair Regen. 2002 Mar-Apr;10(2):118-21. doi: 10.1046/j.1524-475x.2002.00205.x. No abstract available.
- Results publication: PubMed 12032371Musgrave MA, Umraw N, Fish JS, Gomez M, Cartotto RC. The effect of silicone gel sheets on perfusion of hypertrophic burn scars. J Burn Care Rehabil. 2002 May-Jun;23(3):208-14. doi: 10.1097/00004630-200205000-00010.
- Results publication: PubMed 3690373Quinn KJ. Silicone gel in scar treatment. Burns Incl Therm Inj. 1987 Oct;13 Suppl:S33-40. doi: 10.1016/0305-4179(87)90091-x. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuei-Chang Hsu, surgeon principal investigator
Department of plastic surgery in Kaohsiung Veterans General Hospital in Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing silicone gel, silicone sheet and paper tape in people with Hypertrophic Scars, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar appearance measured with Vancouver Scar Scores. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00849004, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2012.