Clinical Data


Keloid and Hypertrophic Scars are raised progressive scars, characterized by being voluminous, and occasionally erythematous. The patient may remain asymptomatic or experience pain and/or pruritis. Depending on location, the lesion is frequently accompanied by psychological ramifications of discomfort and disfigurement. Until now, there has been no clinically effective therapy (surgical or nonsurgical) to remove keloid and hypertrophic scars.

The CryoShape methodology signifies a novel and efficacious therapeutic advance in this field of therapeutics. One minor in-office procedure in the majority of cases will suffice to eliminate the keloid.

Several clinical studies clearly demonstrated the efficacy of the CryoShape due to its rapid and effective freezing of the deep scar.

Clinical data and patient follow-up have confirmed dramatic results from CryoShape treatment for keloid and hypertrophic scar removal, far surpassing traditional methods including intralesional steroid injections, laser resurfacing, excisional surgery, radiation therapy, topical agents, and pressure therapy. CryoShape typically requires only a single treatment session, with almost immediate alleviation of itching, pain, and tenderness. Even more compelling, CryoShape has been designed to eliminate or dramatically minimize any recurrence of raised or thickened scars.

Clinical results have demonstrated over 93% of patients treated with CryoShape have shown significant improvement and long-term results. An average of about 60% of scar volume reduction was achieved following a single treatment session. The CryoShape treatment preserved the original skin color with no hypo-pigmentation in 87% of the cases.

The clinical results clearly show significant improvement in quality of life:

  • Pruritus and discomfort reduced by 55%
  • Pain and tenderness was decreased by 75%
  • Hardness decreased by an average of 67%
  • Erythema decreased by 50%

J Eur Acad Dermatol Venereol. 2011 Sep;25(9):1027-36. doi: 10.1111/j.1468-3083.2010.03911.x. Epub 2010 Nov 25.

Keloid histopathology after intralesional cryosurgery treatment.
Har-Shai Y, Mettanes I, Zilberstein Y, Genin O, Spector I, Pines M.

Source

Department of Plastic Surgery, The Bruce Rappaport Faculty of Medicine, Carmel Center, Technion-Israel.

Abstract

Background:

Keloid presents a great healthcare challenge. The patients suffer from aesthetic disfiguration and occasionally from pruritus, pain and discomfort. Although various treatments are recommended, a single, highly effective treatment represents a great clinical need.

Objective:

The cellular events and histopathology that follow intralesional cryosurgery were evaluated including cell proliferation, the number of cells expressing fibroblast markers, collagen synthesis and organization and mast cell infiltration.

Methods:

Biopsies were collected before and after intralesional cryoneedle procedure. Collagen structure was evaluated with confocal microscopy. Mast cells, blood vessels and cell proliferation were evaluated using immunohistochemistry.

Results:

Keloids contain abnormally thick collagen bundles, organized in swirls comprising closely bound fibrils. After intralesional cryosurgery, the collagen bundles lost their swirl structure, the thickness of the collagen layer decreased, and the bundles became more compact with less space between the fibres. A clear distinct transition zone separated the treated from the unaffected area. The frozen tissue was devoid of proliferating cells and mast cells whereas the number of blood vessels remained unaltered. Most of the fibroblasts expressed all tested myofibroblast markers although some exclusively expressed one and not the other. Few nuclei were observed in the affected area after treatment and very few of them expressed any fibroblast markers.

Conclusions:

Intralesional cryosurgery resulted in major changes in collagen structure and organization. The treatment reduced the number of proliferating cells, of myofibroblasts and of mast cells. These results may explain the reduction in no-response rate and the amelioration of the clinical symptoms after intralesional cryosurgery treatment.
Journal of the European Academy of Dermatology and Venereology ©2010 European Academy of Dermatology and Venereology. No claim to original US government works.
PMID: 21108665

[PubMed - indexed for MEDLINE]

Int J Low Extrem Wounds. 2008 Sep;7(3):169-75.

Intralesional cryosurgery for the treatment of hypertrophic scars and keloids following aesthetic surgery: the results of a prospective observational study.

Har-Shai Y, Brown W, Labbé D, Dompmartin A, Goldine I, Gil T, Mettanes I, Pallua N.

Source

The Bruce Rappaport Faculty of Medicine, Unit of Plastic Surgery, Carmel Medical Center, Israel Institute of Technology, Technion, Haifa, Israel. yaron07@yahoo.com

Abstract

Hypertrophic scars and keloids following aesthetic surgery, which ignite patient dissatisfaction, are difficult to handle. Intralesional cryosurgery for the treatment of such scars has been introduced. This study was designed to evaluate the efficacy of this technology in the treatment of such scars and to assess the reduction of dissatisfaction. Eleven scars (on 11 patients) were treated by intralesional cryosurgery, following breast surgery, otoplasty, facelifting, and brachioplasty. Each patient scored the concern from the scar and the scar deformity (scale from 1 to 5) prior and following treatment (higher score represents least satisfaction and a severe deformity). The follow-up period was between 3 months and 8 years. The results demonstrated a significant reduction in concern and deformity scores compared with before the cryotreatment (P = .001). The intralesional cryosurgery technique provides the plastic surgeon with an effective instrument to treat hypertrophic scars and keloids following aesthetic surgery, thus reducing the dissatisfaction of patients.

PMID:18757392
[PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/12711943

Plast Reconstr Surg. 2003 May;111(6):1841-52.

Intralesional cryotherapy for enhancing the involution of hypertrophic scars and keloids.
Har-Shai Y, Amar M, Sabo E.

Source

Unit of Plastic Surgery and Department of Pathology, Carmel Medical Center, Haifa, Israel. yaron07@yahoo.com

Abstract

Although therapeutic management of hypertrophic scars and keloids using contact or spray cryosurgery has yielded significant improvement or complete regression of hypertrophic scars and keloids, it requires one to 20 treatment sessions. This study was designed to assess the clinical safety and efficacy of an intralesional needle cryoprobe method in the treatment of hypertrophic scars and keloids. Ten patients, ranging in age from 3 to 54 years, with a total of 12 hypertrophic scars and keloids of more than 6 months duration and of diverse causes, were included in this study. The 18-month trial evaluated volume reduction of the hypertrophic scars and keloids after a single session of intralesional cryotherapy. Objective (hardness and color) and subjective (pain/tenderness and itchiness/discomfort) parameters were examined on a scale of 0 to 3 (low score was better). Pretreatment and posttreatment histomorphometric studies of the collagen fibers included spectral picrosirius red polarization and fast Fourier transformation orientation index. A specially designed cryo-needle was inserted into the long axis of the hypertrophic scars and keloids so as to maximize the volume of the hypertrophic scars and keloids to be frozen. The cryo-needle was connected by an adaptor to a cryogun filled with liquid nitrogen, which was introduced into the cryoprobe, thereby freezing the hypertrophic scars and keloids. After the hypertrophic scars and keloids were completely frozen, the cryoprobe defrosted and was withdrawn. An average of 51.4 percent of scar volume reduction was achieved after one session of intralesional cryosurgery treatment (average preoperative hypertrophic scars and keloids volume, 1.82 +/- 0.33; average posttreatment volume, 0.95 +/- 0.21; p < 0.0022). Significant alleviation of objective and subjective clinical symptoms was documented. Mild pain or discomfort during and after the procedure was easily managed. Only mild local edema and epidermolysis, followed by a short reepithelialization period, were evident. During the 18-month follow-up period, there was no evidence of bleeding, infection, adverse effects, recurrence, or permanent depigmentation. The histomorphometric analysis demonstrated rejuvenation of the treated scars (i.e., parallelization) and a more organized architecture of the collagen fibers compared with the pretreated scars. This study demonstrated the increased efficacy of this method as a result of increased freezing area of deep scar material compared with that obtained with contact/spray probes. As a result, fewer treatment cycles are needed. Because the reepithelialization period is short, treatment intervals, if any, can be shortened to 2 to 3 weeks. This intralesional cryoneedle method is simple to operate and safe to use, it necessitates less postoperative care of the wound, and it can easily be added to any preexisting cryosurgical unit.
PMID:12711943 [PubMed - indexed for MEDLINE]

PMID: 21108665 [PubMed - indexed for MEDLINE]