Clinical trial NCT05194969: Wet-to-dry vs Petrolatum & Non-stick Dressings After Hidradenitis Suppurativa Surgery
Official title: Comparison of Wet-to-dry vs Petrolatum and Non-stick Dressing for Second Intention Healing Following Hidradenitis Suppurativa Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hidradenitis Suppurativa
Surgical Wound
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-01-18
Enrollment: 74
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a randomized, blinded trial of two postoperative bandaging techniques: wet-to-dry dressings vs. petrolatum with non-stick bandaging.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Wound QOL Survey Score Over Time
timeFrame: Administered at 1, 2, 4 and 6 weeks post-surgery
measure: PUSH Score Over Time
timeFrame: Completed at 1, 2, 4 and 6 weeks post-surgery utilizing images submitted by patients
measure: Pain With Dressing Changes Over Time
timeFrame: Collected at 1, 2, 4 and 6 weeks post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC School of Medicine Department of Dermatology
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Christopher J Sayed, MD
role: STUDY_DIRECTOR
affiliation: University of North Carolina, Chapel Hill
name: Franklin R Blum, BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Zee HH, Jemec GB. New insights into the diagnosis of hidradenitis suppurativa: Clinical presentations and phenotypes. J Am Acad Dermatol. 2015 Nov;73(5 Suppl 1):S23-6. doi: 10.1016/j.jaad.2015.07.047.
citation: von der Werth JM, Williams HC. The natural history of hidradenitis suppurativa. J Eur Acad Dermatol Venereol. 2000 Sep;14(5):389-92. doi: 10.1046/j.1468-3083.2000.00087.x.
citation: Ring HC, Theut Riis P, Miller IM, Saunte DM, Jemec GB. Self-reported pain management in hidradenitis suppurativa. Br J Dermatol. 2016 Apr;174(4):909-11. doi: 10.1111/bjd.14266. Epub 2016 Jan 6. No abstract available.
citation: Ingram JR, Jenkins-Jones S, Knipe DW, Morgan CLI, Cannings-John R, Piguet V. Population-based Clinical Practice Research Datalink study using algorithm modelling to identify the true burden of hidradenitis suppurativa. Br J Dermatol. 2018 Apr;178(4):917-924. doi: 10.1111/bjd.16101. Epub 2018 Feb 22.
citation: Augustin M, Conde Montero E, Zander N, Baade K, Herberger K, Debus ES, Diener H, Neubert T, Blome C. Validity and feasibility of the wound-QoL questionnaire on health-related quality of life in chronic wounds. Wound Repair Regen. 2017 Sep;25(5):852-857. doi: 10.1111/wrr.12583. Epub 2017 Nov 2.
citation: Stotts NA, Rodeheaver GT, Thomas DR, Frantz RA, Bartolucci AA, Sussman C, Ferrell BA, Cuddigan J, Maklebust J. An instrument to measure healing in pressure ulcers: development and validation of the pressure ulcer scale for healing (PUSH). J Gerontol A Biol Sci Med Sci. 2001 Dec;56(12):M795-9. doi: 10.1093/gerona/56.12.m795.
citation: Thompson N, Gordey L, Bowles H, Parslow N, Houghton P. Reliability and validity of the revised photographic wound assessment tool on digital images taken of various types of chronic wounds. Adv Skin Wound Care. 2013 Aug;26(8):360-73. doi: 10.1097/01.ASW.0000431329.50869.6f.
citation: Eaglstein WH, Davis SC, Mehle AL, Mertz PM. Optimal use of an occlusive dressing to enhance healing. Effect of delayed application and early removal on wound healing. Arch Dermatol. 1988 Mar;124(3):392-5.