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N/A N=74 Randomized Triple-blind Supportive Care

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

Hidradenitis Suppurativa · Surgical Wound

Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Wound QOL Survey Score Over Time — 1.14; 0.94; 0.77; 0.66 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Wet-to-Dry Dressings (Device); Petrolatum with Non-Stick Gauze (Device)
Age
Pediatric, Adult, Older Adult · 16+ yrs
Sex
All
Sponsor
University of North Carolina, Chapel Hill
Primary completion
Oct 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Wound QOL Survey Score Over Time
1.14; 0.94; 0.77; 0.66; 0.51; 0.54
PRIMARY
PUSH Score Over Time
11.0; 11.4; 9.1; 10.0; 5.7; 6.2
PRIMARY
Pain With Dressing Changes Over Time
6.2; 3.6; 3.5; 2.3; 2.1; 1.6

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05194969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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