Pressure Device in the Treatment of Ear Keloids

NCT ID: NCT02962518

Last Updated: 2016-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-10-31

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.

Conditions

Keloid Ear

Keywords

Pressure Device; Clip; Triamcinolone; Fillet Technique

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A Standard Treatment

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

Group Type: ACTIVE_COMPARATOR

Fillet Technique

Intervention Type: 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.

Triamcinolone

Intervention Type: DRUG

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

B 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 are additionally treated with a non-customized pressure device.

Group Type: EXPERIMENTAL

Pressure Device

Intervention Type: 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.

Fillet Technique

Intervention Type: 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.

Triamcinolone

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Triamcinolone

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

Intervention Type: DRUG

Other Intervention Names

Volon A

Eligibility Criteria

Inclusion Criteria

• Keloids of the helical rim of the ear

Exclusion Criteria

• immunodeficiency
• infectious disease
• missing capacity for consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Thomas Hoffmann

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas K Hoffmann, Prof. Dr.

Role: STUDY_CHAIR

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

Locations

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

Ulm, , Germany

Countries

Germany

Other Identifiers

68/14

Identifier Type: -

Identifier Source: org_study_id