KeloidNCT02005055
High Dose Rate Brachytherapy for Treatment of Keloids
An observational study of Keloid, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
This prospective study evaluates the outcome of surgical excision with adjuvant high-dose-rate brachytherapy for the treatment of recalcitrant keloids. Main outcomes are recurrence rate, scar quality and physical complaints. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Keloid
- What is being tested?
- Surgical excision with adjuvant high-dose-rate brachytherapy
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2003to Dec 2010
- Phase
- Observational
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with recalcitrant keloids meeting inclusion criteria
Who may be able to join
- Keloid defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr)
- the keloid had been proven insensitive to at least one other treatment
- patients had to be older than 10 years of age.
Who cannot join
- keloids not suitable for excision with primary closure due to its size or anatomical location
- pregnancy or diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of the Use of High-dose-rate Brachytherapy for the Treatment of Recalcitrant Keloids
This prospective study evaluates the outcome of surgical excision with adjuvant high-dose-rate brachytherapy for the treatment of recalcitrant keloids. Main outcomes are recurrence rate, scar quality and physical complaints.
Read the detailed description
This prospective evaluation describes the outcome of surgical excision with adjuvant high-dose-rate brachytherapy for the treatment of recalcitrant keloids in a large mixed Fitzpatrick skin type patient population. After intralesional excision, a unique low dose radiation scheme of 2x6Gray (Gy) was administered in 2 fractions: the first within 4 hours, the second within 24 hours. Keloids were evaluated pre- and postoperative (1 week, 3, 6, 12 months, 5years). Scars were measured and recurrence was judged. An evaluation of the outcome of the scars was obtained using the Patient and Observer Scar Assessment Scale. Statistical analyses were conducted using SPSS version 20.0 (SPSS, Inc, Chicago, III)
- Conditions
- Keloid
- Being tested
- Surgical excision with adjuvant high-dose-rate brachytherapy
- Keywords
- Brachytherapy, Radiotherapy, Scar treatment
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical excision with adjuvant high-dose-rate brachytherapyProcedure or surgery
Also called Metal tipped Varisource catheter (external diameter: 1.6mm, length: 150cm, Varian medical systems, Palo Alto, USA), Monocryl 4-0 or 5-0, Iridium-192 remote control afterloader (Varisource, Varian medical systems, Palo Alto, USA)
The keloid was excised extralesionally and subsequently a metal tipped Varisource catheter was positioned between the dermal edges of the wound, 5 mm below the surface of the skin and extending out of the skin beyond the wound. Primary wound closure was performed and patients were transferred to the radiation department, where the catheter was connected to the Iridium-192 remote control afterloader. The planning target volume was defined as a cylinder along the axis of the scar, with a central diameter of 5mm. Patients received 2 fractions of HighDoseRate brachytherapy. Within 4 hours after the resection, the first brachytherapy fraction of 6 Gy at 5mm of the source axis was given. Within 24 hours after the first fraction a second fraction of 6Gy was administered to a total dose of 12Gy in 2 days. After the second fraction the catheter was gently removed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with recalcitrant keloid scars | All patients with keloids insensitive to other treatments Receives: Procedure: Surgical excision with adjuvant high-dose-rate brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Recurrence was defined as a growing, pruritic, nodular scar as described by Cosman and Wolff(1)
Measured: At a minimum of one year post surgery
Secondary outcomes (1)
Scar Quality
The scar (pre-operative) and the residual scar (post-operative at 1 week, 3,6,12 months and 5 year) was examined, photographs were taken, surface area was measured and the 'Patient and Observer Scar Assessment Scale' was obtained (2)
Measured: Pre- and postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startJan 2003
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for KeloidStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michiel van Leeuwen, Amsterdam UMC, location VUmc
- Investigators
- Michiel CE Leeuwen van, MD, Principal investigator, VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005055
- Sponsor's protocol ID
- PlastChirVUmc 01
- Status last verified
- Dec 2013
- First submitted
- 26 Nov 2013
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cosman B, Wolff M. Bilateral earlobe keloids. Plast Reconstr Surg. 1974 May;53(5):540-3. doi: 10.1097/00006534-197405000-00008. No abstract available.
PubMed 4821203Draaijers 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 15253184van Leeuwen MCE, Stokmans SC, Bulstra AJ, Meijer OWM, van Leeuwen PAM, Niessen FB. High-dose-rate brachytherapy for the treatment of recalcitrant keloids: a unique, effective treatment protocol. Plast Reconstr Surg. 2014 Sep;134(3):527-534. doi: 10.1097/PRS.0000000000000415.
PubMed 25158710
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Use of High-dose-rate Brachytherapy for the Treatment of Recalcitrant Keloids
- ClinicalTrials.gov ID
- NCT02005055
- Acronym / sponsor ID
- PlastChirVUmc 01
- Conditions
- Keloid
- Keywords
- Brachytherapy, Radiotherapy, Scar treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Dec 2013 (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.
This prospective study evaluates the outcome of surgical excision with adjuvant high-dose-rate brachytherapy for the treatment of recalcitrant keloids. Main outcomes are recurrence rate, scar quality and physical complaints.
Detailed description
This prospective evaluation describes the outcome of surgical excision with adjuvant high-dose-rate brachytherapy for the treatment of recalcitrant keloids in a large mixed Fitzpatrick skin type patient population. After intralesional excision, a unique low dose radiation scheme of 2x6Gray (Gy) was administered in 2 fractions: the first within 4 hours, the second within 24 hours. Keloids were evaluated pre- and postoperative (1 week, 3, 6, 12 months, 5years). Scars were measured and recurrence was judged. An evaluation of the outcome of the scars was obtained using the Patient and Observer Scar Assessment Scale. Statistical analyses were conducted using SPSS version 20.0 (SPSS, Inc, Chicago, III)
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with recalcitrant keloid scars | – | Procedure: Surgical excision with adjuvant high-dose-rate brachytherapyAll patients with keloids insensitive to other treatments |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with recalcitrant keloids meeting inclusion criteria
Key inclusion criteria (3 listed)
- Keloid defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr)
- the keloid had been proven insensitive to at least one other treatment
- patients had to be older than 10 years of age.
Key exclusion criteria (2 listed)
- keloids not suitable for excision with primary closure due to its size or anatomical location
- pregnancy or diabetes
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 |
|---|---|---|
| Surgical excision with adjuvant high-dose-rate brachytherapyAlso: Metal tipped Varisource catheter (external diameter: 1.6mm, length: 150cm, Varian medical systems, Palo Alto, USA), Monocryl 4-0 or 5-0, Iridium-192 remote control afterloader (Varisource, Varian medical systems, Palo Alto, USA)The keloid was excised extralesionally and subsequently a metal tipped Varisource catheter was positioned between the dermal edges of the wound, 5 mm below the surface of the skin and extending out of the skin beyond the wound. Primary wound closure was performed and patients were transferred to the radiation department, where the catheter was connected to the Iridium-192 remote control afterloader. The planning target volume was defined as a cylinder along the axis of the scar, with a central diameter of 5mm. Patients received 2 fractions of HighDoseRate brachytherapy. Within 4 hours after the resection, the first brachytherapy fraction of 6 Gy at 5mm of the source axis was given. Within 24 hours after the first fraction a second fraction of 6Gy was administered to a total dose of 12Gy in 2 days. After the second fraction the catheter was gently removed. | Procedure or surgery | Patients with recalcitrant keloid scars |
Primary outcome
Recurrence
Time frame: At a minimum of one year post surgery
Recurrence was defined as a growing, pruritic, nodular scar as described by Cosman and Wolff(1)
1 secondary outcome
Scar Quality
Time frame: Pre- and postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
- Background: PubMed 4821203Cosman B, Wolff M. Bilateral earlobe keloids. Plast Reconstr Surg. 1974 May;53(5):540-3. doi: 10.1097/00006534-197405000-00008. No abstract available.
- 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.
- Derived from this study: PubMed 25158710van Leeuwen MCE, Stokmans SC, Bulstra AJ, Meijer OWM, van Leeuwen PAM, Niessen FB. High-dose-rate brachytherapy for the treatment of recalcitrant keloids: a unique, effective treatment protocol. Plast Reconstr Surg. 2014 Sep;134(3):527-534. doi: 10.1097/PRS.0000000000000415.
- VU University medical centerLink provided by the sponsor.
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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.
Michiel CE Leeuwen van, MD principal investigator
VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keloid, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 9 Dec 2013. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recurrence (time frame: At a minimum of one year post surgery). 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 NCT02005055, which also lists 3 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 9 Dec 2013.