Safety and Treatment of Cryoinsufflation in Treatment of Hidradenitis Suppurativa

Study Summary

Hidradenitis suppurativa (HS) is a chronic, socially and cosmetically debilitating disease. It typically manifests as nodules and abscesses that ultimately can progress to form deep sinus tracts, fistulas, and scarring. The lesions are often very painful and can chronically drain malodorous fluid, which can leave affected individuals uncomfortable and self-conscious, or even debilitated. Treatment presents significant challenges and frustration to both the patient and the provider. Measures such as topical antibiotic and antiseptic washes are generally thought to be beneficial for the treatment of early stage HS. When this is not efficacious, systemic antibiotics are prescribed. In some patients, disease remains refractory to these treatments and their fistulas and tracts progress to scarring. In some patients, the disease continues to progress. In these patients who fail conservative medical management and minimally invasive procedures, such as deroofing, is the next step in the therapeutic ladder. In deroofing, the skin overlying the sinus tract is cut, exposing the floor of the tract. These wounds are left open to heal by secondary intention. Also with this technique, recurrence is common. In this study, investigators propose the use of cryoinsufflation for management of the sinus tracts in hidradenitis suppurativa. In this technique, local anesthesia will be administered to the tract area with lidocaine hydrochloride 1% or a similar numbing medication. A needle will be mounted on a cryosurgical unit. The needle will be instered into the tracts at one location on one side of the body and liquid nitrogen will be administered. This will result in obliteration of the sinus tract. This intervention may prevent disease progression and ameliorate the need for these patients to surgically intervene on their disease. Overall, this would result in improved cosmesis, decreased pain, and improved patient satisfaction. The objective of this prospective, randomized controlle

Primary Outcome

Scars will be assessed using The Vancouver Scar Scale. Pigmentation, vascularity, pliability and height will be assessed and assigned a rating using the following: Pigmentation (0-2) Normal (0) Hypopigmentation (1) Hyperpigmentation (2) Vascularity (0-3) Normal (0) Pink (1) Red (2) Purple (3) Pliability (0-5) Normal (0) Supple (1) Yielding (2) Firm (3) Banding (4) Contracture (5) Height (0-3) Normal (flat) (0) 0-2 mm (1) 2-5 mm (2) \>5 mm (3)

Interventions

• OTHER Cryoinsufflation
• OTHER Deroofing