Safety and Treatment of Cryoinsufflation in Treatment of Hidradenitis Suppurativa

NCT05830149 | Terminated

• 1 other identifier: IRB11587
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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 controlled clinical trial is to compare the efficacy of cryoinsufflation in patients with draining sinus tracts versus deroofing while keeping the patients on the medications that they currently on for hidradenitis suppurativa. In deroofing, the sinus tract is found. Local anesthesia is administered to numb the area of the sinus tract. The sinus tract is probed. Then the skin overlying the sinus tract is cut, exposing the floor of the tract. These wounds are then left open to heal by secondary intention. Patients with one anatomic location having Hurley stage 2 disease with at least one recurrent sinus tract will be included in the study. Cryoinsufflation will be compared to deroofing. Patients will be randomized into either the group receiving cryoinsufflation (Group A) or deroofing (Group B). The distribution of patients will be completely random similar to a coin toss. Patients will remain on all systemic hidradenitis suppurativa medications throughout the entire duration of the study. The primary endpoint of the study will be time to obliteration of the sinus tract and pain tolerance of cryoinsufflation. Secondary endpoints will include cosmesis (identified through patient photography) and patient satisfaction (identified through study surveys) as well as comparison to deroofing. Patients in group A will be treated with cryoinsufflation at up to five study visits. If it is determined that the patient's sinus tract has scarred over, that will be the patient's final study visit and cryoinsufflation will not be performed. Patients in group B will be treated with deroofing at the first visit and will return for 2 future visits at 28 day intervals. At the study visits the investigators will examine the site of intervention, take clinical photographs, measure the tract, ultrasound the tract, the study doctor will perform visual assesments of the area, the interventions (both cryoinsufflation and deroofing) will be timed, and patients will complete the survey questionnaires. If determined to be superior in efficacy, the addition of cryoinsufflation as an adjuvant therapy to hidradenitis suppurativa could influence treatment guidelines in hidradenitis management, leading to an improvement in the quality of care delivered, especially in terms of cosmetic outcomes, prevention of disease progression, and patient satisfaction.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Vancouver scar scale to assess efficacy of 1 treatment session every 28 days for up to 5 treatments

  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)

  At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes (3)

• Quality of life changes secondary to study intervention with the DLQI (Dermatology Quality of Life Index) questionnaire

  At the end of Cycle 1 (each cycle is 28 days)

• Safety - adverse event assessment

  At the end of Cycle 1 (each cycle is 28 days)

• Hurley Staging assessment

  At the end of Cycle 1 (each cycle is 28 days)

Study Arms (2)

Cryoinsufflation

EXPERIMENTAL

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.

Other: Cryoinsufflation

Deroofing

ACTIVE COMPARATOR

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.

Other: Deroofing

Interventions

Cryoinsufflation OTHER

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.

Cryoinsufflation

Deroofing OTHER

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.

Deroofing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Pranita Rambhatla, MD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Model Details: Subjects will be randomized to either receiving cryoinsufflation or surgical deroofing

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: April 26, 2023
• Study Start: February 20, 2018
• Primary Completion: April 18, 2018
• Study Completion: April 18, 2018
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)