Wet-to-dry vs Petrolatum & Non-stick Dressings After Hidradenitis Suppurativa Surgery

University of North Carolina (UNC)

Status: Completed

Conditions: Surgical Wound; Hidradenitis Suppurativa

Treatments: Device: Wet-to-Dry Dressings; Device: Petrolatum with Non-Stick Gauze

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05194969

21-1989

Details and patient eligibility

About

Hidradenitis suppurativa (HS) is a chronic, severe, inflammatory skin disease associated with pain, drainage, odor, and disability characterized by recurring abscesses, nodules, and tunneling sinuses in intertriginous locations such as the groin, buttocks, and axillae. HS has more negative impact on patients' quality of life than all other common dermatologic diseases and is common, affecting ~1% of the general population, with higher risk for females (3:1) and Black patients. The onset is often in adolescence. As HS has been under-studied historically, there is an unmet medical need to develop more effective treatment for this disease. While many patients are managed with medications and lifestyle modifications alone, a subset of HS patients benefit from surgical intervention. Proper wound care following HS surgery is paramount, as facilitating proper healing and minimizing infection can prevent post-operative complications, morbidity and the need for future procedures. While many physicians continue to use wet-to-dry dressings as the standard of care for HS patients post-operatively, it is likely that the drawbacks of this dressing technique outweigh the benefits. This study hopes to answer the question of whether or not wet-to-dry dressings should truly be standard of care or whether an alternate form of wound dressings, such as petrolatum with non-stick bandaging, is at least equitable if not superior in effect, and associated with fewer drawbacks such as associated pain and time dedicated to dressing changes. This study will be a randomized, single-blind trial of two postoperative bandaging techniques: wet-to-dry dressings vs. petrolatum with non-stick bandaging. Primary outcomes will be tracked using the photographic wound assessment tool (PWAT), pressure ulcer scale of healing (PUSH) tool, and Wound Quality of Life (QOL) Survey. There is potential for this study to apply to surgical interventions outside of HS, as the study addresses the bandaging technique (wet-to-dry) that is standard of care after many surgical procedures.

Enrollment: 74 patients

Sex: All

Ages: 16 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male & females > or = 16 years of age
• Patient must have undergone a standard-of-care surgical procedure for HS with planned secondary intention healing of the wound.
• Must be able to provide adequate informed consent for themselves
• Patient must be capable of performing either of the recommended wound care regimens on their own or have someone available to consistently assist with wound care.

Exclusion criteria

• Patients with surgically closed wounds (sutures, staples)
• Patients with preference for specific types of bandaging protocols
• Patients that have not been able to tolerate either wet-to-dry or petrolatum and non-stick bandages in the past

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 2 patient groups

Wet-to-dry Dressings

Active Comparator group

Description:

Participants in this arm will receive standard of care wet-to-dry dressings.

Treatment:

Device: Wet-to-Dry Dressings

Petrolatum with Non-Stick Gauze

Experimental group

Description:

Participants in this arm will receive petrolatum with non-stick gauze.

Treatment:

Device: Petrolatum with Non-Stick Gauze