Pressure Device in the Treatment of Ear Keloids

NACompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

October 31, 2016

Study Completion Date

October 31, 2016

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.

Trial Locations (1)

89075

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

All Listed Sponsors
lead

University of Ulm

OTHER

NCT02962518 - Pressure Device in the Treatment of Ear Keloids | Biotech Hunter | Biotech Hunter