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

Hidradenitis Suppurativa Clinical Trial

Official title:

Comparison of Wet-to-dry vs Petrolatum and Non-stick Dressing for Second Intention Healing Following Hidradenitis Suppurativa Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05194969
• Other study ID #: 21-1989
• Status: Completed
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: January 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa
• Surgical Wound

Intervention

Device:
• 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
• 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.

Locations

Country	Name	City	State
United States	UNC School of Medicine Department of Dermatology	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Wound QOL Survey Score Over Time	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. Total score ranges from 0 to 4 with higher scores indicating a worse outcome.	Administered at 1, 2, 4 and 6 weeks post-surgery
Primary	Change in PUSH Score Over Time	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.	Completed at 1, 2, 4 and 6 weeks post-surgery utilizing images submitted by patients
Primary	Change in Pain with Dressing Changes	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.	Collected at 1, 2, 4 and 6 weeks post-surgery

External Links

•   PUSH Tool
•   Wound QOL Survey