Intralesional cryosurgery for the treatment of keloid scars following cochlear implant surgery and removal of cholesteatoma
The development of hypertrophic scars and keloids is a relatively common complication of different otologic procedures involving incision of the skin behind the ear. This case report aims to describe the successful treatment of keloids that developed following ear surgeries that have been performed via a retro-auricular approach (cochlear implantation and the removal of cholesteatoma) by an intralesional cryosurgery method. Two patients who were previously operated for an extensive pediatric cholesteatoma and one patient who underwent a cochlear implant surgery have developed large keloids at the radix helix. The keloids were treated under local anesthesia by the intralesional cryosurgery method. Over a 6-month period, the scars gradually flattened and became paler and the clinical symptoms of itchiness, pain, and tenderness have significantly been reduced. No complications were documented, and there were no recurrences in a follow-up period of 30 months. This case report demonstrates that intralesional cryosurgery provides the surgeon with an effective method to treat keloid scars following the removal of cholesteatoma or cochlear implantation, thus improving the quality of life and body image and enabling the patients to use the implanted device in an adequate and satisfactory way.
Level of Evidence: Level V, therapeutic study.
KeywordsKeloidIntralesional cryosurgeryOtologic surgeryCholesteatomaCochlear implant surgery
The development of hypertrophic scars and keloids is a relatively common complication of different otologic procedures involving incision of the skin behind the ear. Ajalloueyan et al. reported a range of 1.5–6.4 % of keloids that developed in different age groups (<1 to >4 years) following pediatric cochlear implantation surgery . Kempf et al. have stated a reduced incidence of keloid formation of 2.43 % among pediatric patients in whom cochlear implants were inserted surgically . This rare and serious complication necessitated wound debridement, cochlear implant removal, and skin coverage with a flap . Tunkel recorded that following a Z-meatoplasty for modified radical mastoidectomy in children, 1 in 29 operated ears has developed a keloid scar (3.4 %) . Backer and Converse reported that following surgery of protruding ears, the incidence of keloid scars developing in the posterior auricular sulcus was 11 % in African American population compared with 2.1 % in Caucasian . Leist demonstrated that following face-lift surgery, 11.8 % of the 119 patients have complaints regarding the post-auricular scars . Park and Chang have reported that the ear is the most frequent location to develop keloids in adolescence (12–18 years old) . The development of keloids at the retro-auricular area may be attributed to the creation of high skin tension following middle ear or external ear surgery as well as an individual intrinsic abnormal response to extracellular signals causing excessive collagen production and decreased degradation of fibrotic scar tissue . Strohm has raised the possibility of an individual predisposition for excessive fibrosis following the excision of cholesteatoma .
Since the usual skin incision for cochlear implantation is post-auricular and occasionally is extended beyond and anteriorly to the radix helix, keloid formation in this area can prevent the patient from wearing the external device (the sound processor), causing pain, tenderness, and itchiness, which will prevent the patient from using his new cochlear implant in a satisfactory and adequate way. Repeated surgical excisions of the keloids might cause further complications such as keloid recurrence, enlargement of the scars, magnet wound, and skin flap failure and wound infection . A retro-auricular incision is used by most otologic surgeons for the removal of cholesteatoma. The high recidivism rate of cholesteatoma and the need for repeated surgery in many cases predispose the growth of post-operative keloid in this area.
We describe three patients in which a single intralesional cryosurgery was employed to successfully treat large keloids on the anterior radix helix following cochlear implantation surgery and mastoidectomy for the removal of cholesteatoma.
Material and methods
Intralesional cryosurgery of the scars was suggested to the patients, who all agreed to be treated by this method [10–17]. Under translesional local anesthesia  with Bupivacaine HCl injection, USP 0.5 % (Kamacaine 0.5 %, Kamada, Beit Kama, Israel), the cryoprobe (CryoShape, Etgar Group International Ltd., Raanana, Israel; approved by the FDA, CE, and Israeli Ministry of Health), which consists of an elongated double-lumen uninsulated needle with a safety vent and a closed sharp cutting tip, is inserted into the long axis and mid-height of the auricular scar . The cryoneedle is introduced into the core of the scar and is connected by an elongation tube to a liquid nitrogen canister (CryoPro Plus, 500 cc, Cortex Technology, Hadsund, Denmark). By activating the trigger of the canister, liquid nitrogen is pressurized to flow through the needle, which leads to the formation of an ice ball around it, thus causing the abutting scar tissue to freeze completely (Fig. 2b). The ice ball extends beyond the scar borders for about 5 mm to create a halo. Following the entire freezing of the scar, the cryoneedle is withdrawn and the cryosurgery procedure is terminated.
Following the intralesional cryosurgery treatment, a blister formed which drained for about a week. The patients were instructed to wash the cryowound daily with soap and water and to apply an antibiotic ointment (Bactroban; Brampton, Ontario, Canada; mupirocin 2 %, Taro Pharmaceuticals Inc.) twice a day. The patients were scheduled for follow-up visits every 2 weeks until healing of the wound by secondary intension took place, i.e., complete epithelization with no discharge from the wound. Thereafter, they were scheduled for periodic visits for a 30-month period. In each visit the treated site was inspected and each patient was questioned about any complaints or side effects during and after the healing period. All lesions were photographed before, during, and immediately after the freezing process as well as on each follow-up visit. Over a 6-month period, the scars gradually flattened and became paler and soft (Figs. 2, 3, and 4) and the clinical symptoms of itchiness, pain, and tenderness have significantly been reduced. No complications were documented, and there were no recurrences in a follow-up period of 30 months (Figs. 2, 3, and 4).
The patient was allowed to place his cochlear implant processor behind the ear 1 month following the complete healing of the cryotreated wound.
Various clinical options to treat keloids at the retro-auricular area include  intralesional injection of corticosteroids (usually triamcinolone), core or complete surgical excision and closure by a local skin flap or full-thickness skin grafts, CO2 laser, application of silicone gel sheeting, spray or contact cryosurgery, shaving combined with cryotherapy , intralesional injections of 5-fluorouracil or interferon, and radiation therapy or brachytherapy with or without surgical excision. However, there is no solid evidence that these methods are effective in prevention of keloid recurrence [8,18].
It has been stated by Keveton that if an extensive scar tissue or keloid develops following mastoidectomy, the keloid should be excised . It is well documented in the medical literature that surgical removal of keloids, although temporarily gratifying, is almost invariably followed (50–100 %) by even more aggressive re-growth of scar tissue . Therefore, all efforts should be made to use alternative therapeutic modalities, which are not surgical, for the successful treatment of keloids.
The evidence-based novel intralesional cryosurgery method for the treatment of hypertrophic scars and keloids was recently introduced. This method was shown to be effective in the treatment of auricular hypertrophic scars and keloids  and has achieved significant superior clinical results when compared with the existing treatment modalities. In addition, it was demonstrated that this method has significantly reduced the patient concern and deformity scores in a scale from 1 (no concern and or deformity) to 5 (severe concern and deformity) in 11 patients in whom keloids developed following aesthetic surgery including lop ear repair . It is concluded that intralesional cryosurgery provides the plastic surgeon with an effective method to treat such scars following cochlear implantation, thus enabling the patient to use his newly implanted device in an adequate and satisfactory way throughout the day.
The intralesional cryosurgery method has two main advantages over the spray or contact cryosurgery technique. Usually only a single cryosession is needed and much less hypopigmentation due to better survival of melanocytes has been shown. This is important when dealing with patients with a darker-colored skin [10,11,14–16]. These advantages have significant clinical applications for the treatment of hypertrophic scars and keloids, especially on the face, which is the most crucial area of concern for patients. Furthermore, the common treatment modalities for treating such scars require several treatments and a long post-treatment period with an uncertain outcome.
It has been documented by Gage that auricular cartilage is more resistant to permanent freezing injury than the skin is, and, therefore, perforation of the cartilage from cryogenic injury is unusual even if freezing is carried through the entire thickness of the ear . Therefore, the intralesional cryosurgery method when applied to the auricular area is safe and will not cause damage or deformation to the cartilage and the ear.
To our knowledge, this technique of intralesional cryosurgery for treating keloid scars following cochlear implantation and the excision of cholesteatoma is the first to be published in the medical literature.
Different incisions are recommended  for cochlear implantation such as “J shaped,” “straight,” “lazy S” , “endomeatal,” “anteriorly based C shaped,” “inverted U shaped,” and “hockey stick” , in which each incision is analyzed for its advantages of blood supply and cosmetic incision line.
Ajalloueyan et al. have reported that in their experience with the first 75 patients using the classic “C” incision, flap necrosis, and explantation of the device occurred in one case . Also in view of concerns for the cosmetic result with the classic C-shaped design of the flap, it was converted by the authors to a modified hockey stick design . This “new” designed incision avoids devascularization of the flap and creates a less visible incision line with minimal continuation over the helix. In their report the development of keloid scars was rare.
Therefore, when planning for otologic surgery, the surgeon should consider the design of the flap and its location in order to ensure optimal arterial supply and venous and lymphatic drainage. This will have a bearing on the possible growth of hypertrophic and keloid scars. Furthermore, the surgeon should plan limited retro-auricular incisions that will not extend forward to the radix helix, which was shown to be a location that has a high prevalence of the development of proliferating scars and keloids. Further studies are needed on a larger scale to verify the above promising results and which may also broaden the indication for application.
Compliance with ethical standards
This study was not funded.
Conflict of interest
Yaron Har-Shai has a financial interest in the intralesional cryosurgery technology. Ariel Roitman and Michal Luntz declare that they have no conflict of interest.
This study was approved by the Institutional Ethical Committee (HTA1411), Carmel Medical Center, and the Medical Devices Department (Registered Number 2800-0000), Health Technology and Infrastructure Administration, Israel Ministry of Health.
The patient’s parents or the patient himself signed an informed consent prior to the cryotreatment. Additional consent was obtained for the use of their mages.