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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2023-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hidradenitis Suppurativa Surgical Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will be a randomized, blinded trial of two postoperative bandaging techniques: wet-to-dry dressings vs. petrolatum with non-stick bandaging.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Following the surgical procedure, the principal investigator (PI) will exit the exam room. The PI will not be present for bandaging administration and training and thus be blinded to the wound dressing technique. The patient will not be blinded as bandaging will be administered at home.

Study Groups

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Wet-to-dry Dressings

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

Group Type ACTIVE_COMPARATOR

Wet-to-Dry Dressings

Intervention Type DEVICE

This dressing technique involves moistening a piece of gauze with normal saline or other cleansing solution, placing the moistened gauze on the wound, allowing the gauze to dry, and then removing and replacing the bandage regularly over a period of days to weeks

Petrolatum with Non-Stick Gauze

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

Group Type EXPERIMENTAL

Petrolatum with Non-Stick Gauze

Intervention Type DEVICE

This dressing approach involves applying a thick layer of petrolatum to the wound once or twice daily to maintain a moist wound base. After placement of petrolatum, the wound is covered with nonadherent gauze and tape or another bordered dressing.

Interventions

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Wet-to-Dry Dressings

This dressing technique involves moistening a piece of gauze with normal saline or other cleansing solution, placing the moistened gauze on the wound, allowing the gauze to dry, and then removing and replacing the bandage regularly over a period of days to weeks

Intervention Type DEVICE

Petrolatum with Non-Stick Gauze

This dressing approach involves applying a thick layer of petrolatum to the wound once or twice daily to maintain a moist wound base. After placement of petrolatum, the wound is covered with nonadherent gauze and tape or another bordered dressing.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No