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Pressure Device in the Treatment of Ear Keloids

NCT02962518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-11-11

No results posted yet for this study

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

Interventions

DEVICE

Pressure 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.

PROCEDURE

Fillet Technique

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.

DRUG

Triamcinolone

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

Sponsors & Collaborators

  • University of Ulm

    lead OTHER

Principal Investigators

  • Thomas K Hoffmann, Prof. Dr. · Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Ulm, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02962518 on ClinicalTrials.gov