Pressure Device in the Treatment of Ear Keloids

NCT02962518 | Completed

• 1 other identifier: 68/14
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Keloid Ear

Keywords

Pressure Device; Clip; Triamcinolone; Fillet Technique

Outcome Measures

Primary Outcomes (1)

• Recurrence

  Keloid recurrence

  12 months

Secondary Outcomes (2)

• Aesthetic scar outcome after treatment

  12 months

• Patients satisfaction

  12 months

Study Arms (2)

A Standard Treatment

ACTIVE COMPARATOR

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

Procedure: Fillet Technique; Drug: Triamcinolone

B Pressure Device

EXPERIMENTAL

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.

Device: Pressure Device; Procedure: Fillet Technique; Drug: Triamcinolone

Interventions

Pressure Device DEVICE

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.

B Pressure Device

Fillet Technique PROCEDURE

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.

A Standard Treatment; B Pressure Device

Triamcinolone DRUG

All patients received intra-lesional injections of tiamcinolone 10mg/ml every 4 to 6 weeks for 6 months.

Also known as: Volon A

A Standard Treatment; B Pressure Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Keloids of the helical rim of the ear

You may not qualify if:

• immunodeficiency
• infectious disease
• missing capacity for consent

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

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

Ulm, 89075, Germany

Location

MeSH Terms

Interventions

Triamcinolone

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Thomas K Hoffmann, Prof. Dr.

  Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Ulm, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 11, 2016
• Study Start: July 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 11, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)