Pressure Device in the Treatment of Ear Keloids (PRESSURE)

• ClinicalTrials.gov Identifier: NCT02962518
• Recruitment Status: Completed
• First Posted: November 11, 2016
• Last Update Posted: November 11, 2016
• Sponsor: University of Ulm
• Information provided by (Responsible Party): Prof. Dr. Thomas Hoffmann, University of Ulm

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.

Condition or disease	Intervention/treatment	Phase
Keloid Ear	Device: Pressure Device; Procedure: Fillet Technique; Drug: Triamcinolone	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: PRESSURE: Prospektive, Randomisierte Und Kontrollierte Untersuchung Von Lokaler Druckapplikation im Rahmen Der Keloid-Therapie Der Ohrmuschel
• Study Start Date: July 2014
• Actual Primary Completion Date: October 2016
• Actual Study Completion Date: October 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	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.; Other Name: Volon A
Experimental: 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.	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.; Other Name: Volon A

Outcome Measures

Primary Outcome Measures :

1. Recurrence [ Time Frame: 12 months ]
   Keloid recurrence

Secondary Outcome Measures :

1. Aesthetic scar outcome after treatment [ Time Frame: 12 months ]
   assessed by visual analog scale (VAS) scores
2. Patients satisfaction [ Time Frame: 12 months ]
   assessed by questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Keloids of the helical rim of the ear

Exclusion Criteria:

• immunodeficiency
• infectious disease
• missing capacity for consent

Contacts and Locations

Locations

Germany

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

Ulm, Germany, 89075

Sponsors and Collaborators

University of Ulm

Investigators

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

More Information

• Responsible Party: Prof. Dr. Thomas Hoffmann, Prof. Dr., University of Ulm
• ClinicalTrials.gov Identifier: NCT02962518
• Other Study ID Numbers: 68/14
• First Posted: November 11, 2016
• Last Update Posted: November 11, 2016
• Last Verified: November 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Prof. Dr. Thomas Hoffmann, University of Ulm:

Pressure Device; Clip; Triamcinolone; Fillet Technique

Additional relevant MeSH terms:

Keloid; Collagen Diseases; Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Triamcinolone; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs