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Pressure Device in the Treatment of Ear Keloids (PRESSURE)

Primary Purpose

Keloid Ear

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Pressure Device
Fillet Technique
Triamcinolone
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid Ear focused on measuring Pressure Device, Clip, Triamcinolone, Fillet Technique

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Keloids of the helical rim of the ear

Exclusion Criteria:

  • immunodeficiency
  • infectious disease
  • missing capacity for consent

Sites / Locations

  • Department of Otorhinolaryngology, Head and Neck Surgery, University Medial Center Ulm

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A Standard Treatment

B Pressure Device

Arm Description

Patients undergo surgery using the "fillet technique" and intra-lesional injections of triamcinolone 10mg /ml every 4 to 6 weeks for 6 months.

Patients undergo surgery using the "fillet technique" and intra-lesional injections of triamcinolone 10mg /ml every 4 to 6 weeks for 6 months and are additionally treated with a non-customized pressure device.

Outcomes

Primary Outcome Measures

Recurrence
Keloid recurrence

Secondary Outcome Measures

Aesthetic scar outcome after treatment
assessed by visual analog scale (VAS) scores
Patients satisfaction
assessed by questionnaire

Full Information

First Posted
November 4, 2016
Last Updated
November 8, 2016
Sponsor
University of Ulm
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1. Study Identification

Unique Protocol Identification Number
NCT02962518
Brief Title
Pressure Device in the Treatment of Ear Keloids
Acronym
PRESSURE
Official Title
PRESSURE: Prospektive, Randomisierte Und Kontrollierte Untersuchung Von Lokaler Druckapplikation im Rahmen Der Keloid-Therapie Der Ohrmuschel
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Keloids are benign cutaneous lesions, arising from proliferating fibroblasts. Keloids of the ear may occur after helix piercings and are difficult to treat, since they tend to form recurrences. Guidelines suggest multimodal therapy, however, recurrence rates remain high and prospective randomized trials are still missing. To unravel the most effective combination of therapeutic options for keloids of the ear, 20 patients will be enrolled in a prospective, randomized trial. Patients either undergo surgery using the "fillet technique" and intra-lesional injections of triamcinolone 10mg /ml every 4 to 6 weeks for 6 months, or they are additionally treated with a non-customized pressure device.
Detailed Description
The prospective randomized controlled trial will be conducted at the Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Ulm, Germany. 20 patients will be enrolled in the study. Prior to inclusion, informed written consent is obtained from each patient. Patients with immunodeficiency are not included, as well as patients with an infectious disease or patients with a missing capacity for consent. All patients undergo surgery using the fillet technique. To prevent the remaining skin from further damage, the meticulous skin preparation is performed either using the microscope or magnifying glasses. The keloid is "peeled" out of the excessive skin pocket. If necessary skin trimming is performed and non-resorbable monofilament single sutures are placed. The first intracutaneous injection of triamcinolone 10mg/ml is given before wound dressing is placed. A blanching of the lesion marks the endpoint of injection. Cutaneous sutures are removed after approximately 7 days. Injection of triamcinolone is repeated every 4 to 6 weeks for a total of 6 months. When removing the sutures, patients are randomized using consecutive sampling. Patients in group A are treated according to the protocol outlined above, having steroid injections for 6 months after surgical removal of the keloid. Group B involves patients who are additionally treated with non-customized pressure devices. The standardized clips (K. Egner, Dental Technique, Neu-Ulm, Germany) used in our study are available in two different sizes for smaller or larger defects. According to the guidelines of the German Society of Dermatology, patients are advised to wear the clip at least 16 hours per day. Medically approved transparent acrylate is used so that change in skin color and therefore amount of pressure can be observed at all times. Allergic or toxic skin involvement can be visualized through the transparent surface. Adjusting of the clip is done with one or two screws.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid Ear
Keywords
Pressure Device, Clip, Triamcinolone, Fillet Technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A Standard Treatment
Arm Type
Active Comparator
Arm Description
Patients undergo surgery using the "fillet technique" and intra-lesional injections of triamcinolone 10mg /ml every 4 to 6 weeks for 6 months.
Arm Title
B Pressure Device
Arm Type
Experimental
Arm Description
Patients undergo surgery using the "fillet technique" and intra-lesional injections of triamcinolone 10mg /ml every 4 to 6 weeks for 6 months and are additionally treated with a non-customized pressure device.
Intervention Type
Device
Intervention Name(s)
Pressure Device
Intervention Description
Patients undergo surgery using the "fillet technique" and intra-lesional injections of triamcinolone 10mg /ml every 4 to 6 weeks for 6 months and they are additionally treated with a non-customized Pressure Device. The standardized clips (K. Egner, Dental Technique, Neu-Ulm, Germany) used in our study is available in two different sizes for smaller or larger defects. According to the guidelines of the German Society of Dermatology, patients are advised to wear the clip at least 16 hours per day. Medically approved transparent acrylate is used so that change in skin color and therefore amount of pressure can be observed at all times. Allergic or toxic skin involvement can be visualized through the transparent surface. Adjusting of the clip is done with one or two screws.
Intervention Type
Procedure
Intervention Name(s)
Fillet Technique
Intervention Description
Patients undergo surgery using the fillet technique. To prevent the remaining skin from further damage, the meticulous skin preparation is performed either using the microscope or magnifying glasses. The keloid is "peeled" out of the excessive skin pocket. If necessary skin trimming is performed and non-resorbable monofilament single sutures are placed.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Other Intervention Name(s)
Volon A
Intervention Description
All patients received intra-lesional injections of tiamcinolone 10mg/ml every 4 to 6 weeks for 6 months.
Primary Outcome Measure Information:
Title
Recurrence
Description
Keloid recurrence
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Aesthetic scar outcome after treatment
Description
assessed by visual analog scale (VAS) scores
Time Frame
12 months
Title
Patients satisfaction
Description
assessed by questionnaire
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Keloids of the helical rim of the ear Exclusion Criteria: immunodeficiency infectious disease missing capacity for consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas K Hoffmann, Prof. Dr.
Organizational Affiliation
Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Ulm, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Otorhinolaryngology, Head and Neck Surgery, University Medial Center Ulm
City
Ulm
ZIP/Postal Code
89075
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Pressure Device in the Treatment of Ear Keloids

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