Hypertrophic ScarsPhase 3NCT01113125
Scars After Central Venous Catheters
A Phase 3 study testing Betamethason-17-valerate and fusidic acid and Fusidic Acid in people with Hypertrophic Scars and Keloids, run by Mette Møller Handrup at 1 site in Denmark.
Trial summary
Most children with cancer need a central venous catheter. These catheters are typically placed on the anterior thorax, where the risk of hypertrophic scarring and keloid development is greatly enhanced. A significant part of the children who have survived childhood cancer are troubled by their scars. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Hypertrophic Scars, Keloids
- What is being tested?
- Betamethason-17-valerate and fusidic acid and Fusidic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2010to Jul 2016
- Phase
- Phase 3
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All children and adolescents who have a central venous catheter removed at the Childrens Department of Oncology at Aarhus University Hospital Skejby in the period from March 2010 to July 2011
Who cannot join
- Known allergy towards plaster or fusidic acid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Treatment With Glucocorticoids to Prevent Hypertrophic Scars and Keloid Due to Central Venous Access in Children
Most children with cancer need a central venous catheter. These catheters are typically placed on the anterior thorax, where the risk of hypertrophic scarring and keloid development is greatly enhanced. A significant part of the children who have survived childhood cancer are troubled by their scars.
Topical glucocorticoid treatment is known to induce a reduction of the collagen in the connective tissue.
The investigators hypothesize that treatment with topical glucocorticoids for one week before and three weeks after removal of a central venous catheter, will reduce the formation of hypertrophic scarring and keloid development in children.
- Conditions
- Hypertrophic Scars, Keloids
- Being tested
- Betamethason-17-valerate and fusidic acid, Fusidic Acid
- Keywords
- hypertrophic scar, keloid, central venous catheter, children, cancer
- Medical subject headings
- Cicatrix, Hypertrophic, Keloid, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethason-17-valerate and fusidic acidDrug
0.4 cm creme is applied and covered with a plaster (treatment under occlusion). Dosage every second or third day Treatment is started one week before removal of the central venous catheter and continued for four weeks
Fusidic AcidDrug
0.4 cm creme is applied and covered with a plaster (treatment under occlusion). Dosage every second or third day Treatment is started one week before removal of the central venous catheter and continued for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Fucicort | Experimental | Not described Receives: Drug: Betamethason-17-valerate and fusidic acid |
| Fucidin | Placebo comparator | Not described Receives: Drug: Fusidic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal
Measured: Twelve months
Secondary outcomes (3)
Judgement of the scar by Patient and observer scar scale after six months
Measured: six months
Judgement of the scar by Patient and observer scar scale after twelve months
Measured: twelve months
scars measured by the Vancouver Scar Scale six months after central venous catheter removal
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2014 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mette Møller Handrup
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mette Møller Handrup, Aarhus University Hospital
- Investigators
- Henrik Hasle, Professor, Principal investigator, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113125
- Sponsor's protocol ID
- 2009-015163-14
- Other IDs
- 2009-015163-14, 73191198, 20090206, 2009
- Status last verified
- Feb 2014
- First submitted
- 27 Apr 2010
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wolfram D, Tzankov A, Pulzl P, Piza-Katzer H. Hypertrophic scars and keloids--a review of their pathophysiology, risk factors, and therapeutic management. Dermatol Surg. 2009 Feb;35(2):171-81. doi: 10.1111/j.1524-4725.2008.34406.x.
PubMed 19215252Robles DT, Berg D. Abnormal wound healing: keloids. Clin Dermatol. 2007 Jan-Feb;25(1):26-32. doi: 10.1016/j.clindermatol.2006.09.009.
PubMed 17276198Calaminus G, Weinspach S, Teske C, Gobel U. Quality of survival in children and adolescents after treatment for childhood cancer: the influence of reported late effects on health related quality of life. Klin Padiatr. 2007 May-Jun;219(3):152-7. doi: 10.1055/s-2007-973846.
PubMed 17525909Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60. doi: 10.1097/00004630-199005000-00014.
PubMed 2373734Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
PubMed 15253184Hopwood P, Fletcher I, Lee A, Al Ghazal S. A body image scale for use with cancer patients. Eur J Cancer. 2001 Jan;37(2):189-97. doi: 10.1016/s0959-8049(00)00353-1.
PubMed 11166145
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Treatment With Glucocorticoids to Prevent Hypertrophic Scars and Keloid Due to Central Venous Access in Children
- ClinicalTrials.gov ID
- NCT01113125
- Acronym / sponsor ID
- 2009-015163-14
- Conditions
- Hypertrophic Scars, Keloids
- Keywords
- hypertrophic scar, keloid, central venous catheter, children, cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mette Møller HandrupUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 29 Apr 2010 (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.
Most children with cancer need a central venous catheter. These catheters are typically placed on the anterior thorax, where the risk of hypertrophic scarring and keloid development is greatly enhanced. A significant part of the children who have survived childhood cancer are troubled by their scars.
Topical glucocorticoid treatment is known to induce a reduction of the collagen in the connective tissue.
The investigators hypothesize that treatment with topical glucocorticoids for one week before and three weeks after removal of a central venous catheter, will reduce the formation of hypertrophic scarring and keloid development in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fucicort | Experimental | Drug: Betamethason-17-valerate and fusidic acid |
| Fucidin | Placebo comparator | Drug: Fusidic Acid |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All children and adolescents who have a central venous catheter removed at the Childrens Department of Oncology at Aarhus University Hospital Skejby in the period from March 2010 to July 2011
Key exclusion criteria (1 listed)
- Known allergy towards plaster or fusidic acid
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 |
|---|---|---|
| Betamethason-17-valerate and fusidic acid0.4 cm creme is applied and covered with a plaster (treatment under occlusion). Dosage every second or third day Treatment is started one week before removal of the central venous catheter and continued for four weeks | Drug | Fucicort |
| Fusidic Acid0.4 cm creme is applied and covered with a plaster (treatment under occlusion). Dosage every second or third day Treatment is started one week before removal of the central venous catheter and continued for four weeks | Drug | Fucidin |
Primary outcome
scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal
Time frame: Twelve months
3 secondary outcomes
Judgement of the scar by Patient and observer scar scale after six months
Time frame: six months
Judgement of the scar by Patient and observer scar scale after twelve months
Time frame: twelve months
scars measured by the Vancouver Scar Scale six months after central venous catheter removal
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
- Background: PubMed 19215252Wolfram D, Tzankov A, Pulzl P, Piza-Katzer H. Hypertrophic scars and keloids--a review of their pathophysiology, risk factors, and therapeutic management. Dermatol Surg. 2009 Feb;35(2):171-81. doi: 10.1111/j.1524-4725.2008.34406.x.
- Background: PubMed 17276198Robles DT, Berg D. Abnormal wound healing: keloids. Clin Dermatol. 2007 Jan-Feb;25(1):26-32. doi: 10.1016/j.clindermatol.2006.09.009.
- Background: PubMed 17525909Calaminus G, Weinspach S, Teske C, Gobel U. Quality of survival in children and adolescents after treatment for childhood cancer: the influence of reported late effects on health related quality of life. Klin Padiatr. 2007 May-Jun;219(3):152-7. doi: 10.1055/s-2007-973846.
- Background: PubMed 2373734Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60. doi: 10.1097/00004630-199005000-00014.
- Background: PubMed 15253184Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
- Background: PubMed 11166145Hopwood P, Fletcher I, Lee A, Al Ghazal S. A body image scale for use with cancer patients. Eur J Cancer. 2001 Jan;37(2):189-97. doi: 10.1016/s0959-8049(00)00353-1.
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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.
Henrik Hasle, Professor principal investigator
Aarhus University Hospital Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Betamethason-17-valerate and fusidic acid and Fusidic Acid in people with Hypertrophic Scars and Keloids, run by Mette Møller Handrup at 1 site in Denmark.
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 1 inclusion and 1 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 12 Feb 2014. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal (time frame: Twelve 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 NCT01113125, which also lists 6 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 12 Feb 2014.