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

Not Applicable

Completed

• Conditions: Hidradenitis Suppurativa; Surgical Wound
• Interventions: Device: Wet-to-Dry Dressings; Device: Petrolatum with Non-Stick Gauze

• Registration Number: NCT05194969
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-18
• Study Start: 2022-04-25
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Status Verified: 2024-01
• Results First Submitted: 2024-08-02
• Results First Submitted QC: 2024-08-02
• Last Update Submitted: 2024-08-02
• Results First Posted: 2024-08-28
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wet-to-dry Dressings	Wet-to-Dry Dressings	Participants in this arm will receive standard of care wet-to-dry dressings.
Petrolatum with Non-Stick Gauze	Petrolatum with Non-Stick Gauze	Participants in this arm will receive petrolatum with non-stick gauze.

Primary Outcome Measures

Name	Time	Method
Pain With Dressing Changes Over Time	Collected at 1, 2, 4 and 6 weeks post-surgery	The numeric rating scale (NRS) will be used, where patients will be asked to rate pain with dressing changes and general pain on a scale from 0-10 with higher scores indicating worse pain. This information will be collected in the patient survey that is sent post-operatively.
PUSH Score Over Time	Completed at 1, 2, 4 and 6 weeks post-surgery utilizing images submitted by patients	The pressure ulcer scale for healing (PUSH) tool is a validated means of measuring wound healing over time, specifically wounds that heal via secondary intent, by taking into account things like wound size and wound exudate, among others. Scores range from 0-17 with higher scores indicating inferior wound healing.
Wound QOL Survey Score Over Time	Administered at 1, 2, 4 and 6 weeks post-surgery	A validated Wound Quality of Life (QOL) Survey will be administered that focuses on patient-reported outcomes of level of wound pain, pain with dressing changes (application and removal), satisfaction with the bandaging, and ease of application of the bandaging, all 17 elements on a 0-4 scale. A mean score is calculated using each component such that a total score ranges from 0 to 4 with higher scores indicating a worse outcome.

Trial Locations

Locations (1)

UNC School of Medicine Department of Dermatology; 🇺🇸 Chapel Hill, North Carolina, United States