Safety and Treatment of Cryoinsufflation in Treatment of Hidradenitis Suppurativa
Hidradenitis Suppurativa
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa
Eligibility Criteria
Inclusion Criteria: Be at least 18 years old. Have a diagnosis of HS. Patients must HS with one anatomic location being Hurley stage 2 disease, with one or more widely separated, recurrent sinus tracts. Sinus tracts must measure < 5 cm in length. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form. Agree to follow and undergo all study-related procedures. Exclusion Criteria: Patients who are pregnant or breast feeding will not be able to take part in the study due to the unknown effects of cryoinsufflation. Any reason the investigator feels the patient should not participate in the study. If a patient misses ≥ 2 consecutive study visits, the patient will be excluded from further participation in this trial. Patients who have a history of keloid scarring. Patients planning to undergo surgery intervention for hidradenitis suppurativa during the study period. Patients with a history of kidney or liver disease.
Sites / Locations
- Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cryoinsufflation
Deroofing
In cryoinsufflation, local anesthesia will be administered to the tract area with lidocaine hydrochloride 1% or a similar local anesthetic. A needle will be mounted on a liquid nitrogen cryosurgical unit. The needle will be inserted through the entire sinus tract and cryospray will be delivered to the length of the sinus tract as the needle is retracted with the intention to induce local tissue destruction. Each spray will be 5 seconds in duration and each tract will be sprayed 3 times per treatment session. This technique has been shown to be effective in sinus tract obliteration. This intervention may prevent local disease progression and prevent patients from undergoing more invasive surgeries. Overall, this would result in improved cosmesis, decreased pain, decreased bleeding and improved patient satisfaction.
Deroofing will serve as the control group as this is a minimally invasive procedure that is used for sinus tracts in HS. Studies have demonstrataed the efficacy of deroofing in treating the draining sinus tracts in HS. The control group should have decreased drainage, pain, recurrence, and scarring. In deroofing, local anesthesia will be administered to the tract area with lidocaine hydrochloride 1% or a similar local anesthetic. The sinus tract is probed to clearly defined the sinus tract. The skin overlying the sinus tract is cut using an a scalpel. In this way, the top of the sinus tract is surgically removed. In this way, the top of the sinus tract is surgically removed. The floor of the sinus tract is exposed and left open to heal by secondary intention.