Intralesional cryotherapy versus excision and corticosteroids or brachytherapy for keloid treatment: Study protocol for a randomised controlled trial

Trials (Impact Factor: 1.73). 12/2013; 14(1):439. DOI: 10.1186/1745-6215-14-439
Source: PubMed


Keloids are a burden for patients due to physical, aesthetic and social complaints and treatment remains a challenge because of therapy resistance and high recurrence rates. The main goal of treatment is to improve the quality of life (QoL); this implies that, apart from surgical outcomes, patient-reported outcome measures (PROMs) need to be taken into account. Decision making in keloid treatment is difficult due to heterogeneity of the condition and the lack of comparative studies.Methods/design: This is a multicentre, randomised controlled open trial that compares 1) intralesional cryotherapy versus excision and corticosteroids for primary keloids, and 2) intralesional cryotherapy versus excision and brachytherapy for therapy-resistant keloids. The primary outcome is the Patient and Observer Scar Assessment Scale (POSAS), a 12-item scale (with score 12 indicating the best and 120 indicating the worst scar imaginable). A difference of six points on the total score is considered to be of clinical importance. Secondary outcomes are recurrence rates, volume reduction, Skindex-29 scores, SF-36 scores and complication rates. Primary and secondary outcome measurements are taken at baseline, and at 2, 12, 26 and 52 weeks postoperatively. For analysis, a linear mixed model is used. A total of 176 patients will be included over a period of 2.5 years. The protocol is approved by the Medical Ethics Committee of the Erasmus University Medical Centre Rotterdam and follows good clinical practice guidelines.
The outcomes of this study will improve evidence-based decision making for the treatment of keloids, as well as patient education.Trial registration: Dutch Trial Register NTR4151.

Download full-text


Available from: Frank B Niessen, Mar 11, 2014
  • [Show abstract] [Hide abstract]
    ABSTRACT: No universally accepted standard for evaluation, prevention, and treatment of scars, hypertrophic scars, and keloids exists. Following development of a questionnaire, we performed a closed Web-based survey among burn centers. Server-based data collection was performed over 4 weeks and closed thereafter.The poll revealed emerging new treatment schemes, but the majority of participants adhered to evaluation (Patient and Observer Scar Assessment Scale, Matching Assessment of Scars and Photographs, Vancouver Scar Scale, two-dimensional photography) and prevention (silicone gel sheets and compression garments) strategies that were in line with the currently available recommendations from the literature. We noted a low penetration for the use of objective evaluation tools in our poll and detected differences in surgical approaches to keloids.Based on the results of our survey and the power of currently available clinical recommendations, we expect future guidelines to gain more evidence-based power, especially when more high-quality clinical trials with objective evaluation support, clearly defined disease entities, and therapeutic outcome factors have become available.
    No preview · Article · Jul 2014 · Wound Repair and Regeneration
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background Intralesional (IL) cryotherapy is a new promising technique for the treatment of keloid scars, in which the scar is frozen from inside. Multiple devices are available, mostly based on a simple liquid nitrogen Dewar system, which have a limited freezing capacity. Argon gas based systems ensure accurate and highly controlled freezing and have shown effective within the field of oncologic surgery. However, this technique has never been used for treatment of keloid scars. Objective This prospective study evaluates an argon gas based system for the treatment of keloids in a patient population including all Fitzpatrick skin types with a 1 year follow-up. Methods Twenty-five patients with 30 keloid scars were included and treated with a device called Seednet. Scar quality and possible scar recurrence were assessed pre- and post-treatment (6 and 12 months) with objective devices determining scar color, scar elasticity, scar volume and patient’s skin type. In addition, scars were evaluated using the Patient and Observer Scar Assessment Scale. Results After 12 months, a significant volume reduction of 62% was obtained, p=0,05. Moreover, complaints of pain and itching were alleviated and scar quality had improved according to the Patient and Observer Scar Assessment Scale. Scar pigmentation recovered in 62% of all keloid scars within 12 months. Five out of 30 (17%) scars recurred within 12 months, 3 of which had previously been treated with liquid nitrogen-based IL cryotherapy. Both recurrence and persistent hypopigmentation were mainly seen in Afro-American patients. Conclusions Intralesional cryotherapy with the use of an argon gas based system proves to be effective in the treatment of keloid scars, yielding volume reduction and low recurrence rates. Although hypopigmentation recovered in most cases, it is strongly related to non- Caucasian patients. Finally, additional treatment of keloid scars previously unresponsive to IL cryotherapy, are predisposed to a high recurrence rate. Trial number NCT02063243.
    Full-text · Article · Aug 2014 · Journal of Plastic Reconstructive & Aesthetic Surgery
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background: Keloids cause aesthetic disfigurement and physical complaints, mainly pain and pruritus. Treatment of these scars is difficult, with high recurrence rates forming the main issue. Surgical excision with adjuvant radiotherapy is considered the most efficacious treatment. At their institution, the authors have been treating keloids with a high-dose-rate brachytherapy procedure for over 10 years, using a protocol with the lowest total radiation dosage known in the literature. Methods: This prospective study included 43 patients of all Fitzpatrick skin types, with 67 keloids in total. After extralesional excision, a radiation scheme of 2 x 6 Gy was administered in two fractions: the first within 4 hours after surgery and the second within 24 hours. Scars were measured and recurrence was judged. Scar appearance was evaluated using the Patient and Observer Scar Assessment Scale. Results: The recurrence rate was 3.1 percent at a mean follow-up of 33.6 months. A significant average scar surface decrease of 56.7 percent was measured (p = 0.01). Complaints of pain and pruritus decreased by 82.9 and 87.2 percent, respectively. Patients were satisfied with the treatment in 88.6 percent of the cases and with the cosmetic result in 77.1 percent. Pigmentation problems were seen in 21.4 percent of the patients, mostly in Fitzpatrick type V and VI/African American individuals. Conclusions: The results of this prospective study show a good cosmetic outcome with a low recurrence rate. The unique radiation schedule proves the efficacy and safety of high-dose-rate brachytherapy and suggests the importance of immediate postoperative irradiation. In addition, only one outpatient treatment is required after surgery, enhancing patient convenience.
    No preview · Article · Sep 2014 · Plastic & Reconstructive Surgery