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

Primary Purpose

Hidradenitis Suppurativa, Surgical Wound

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wet-to-Dry Dressings
Petrolatum with Non-Stick Gauze
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hidradenitis Suppurativa

Eligibility Criteria

16 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNC School of Medicine Department of DermatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Wet-to-dry Dressings

Petrolatum with Non-Stick Gauze

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 5, 2022
Last Updated
June 1, 2023
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT05194969
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa, Surgical Wound

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wet-to-dry Dressings
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive standard of care wet-to-dry dressings.
Arm Title
Petrolatum with Non-Stick Gauze
Arm Type
Experimental
Arm Description
Participants in this arm will receive petrolatum with non-stick gauze.
Intervention Type
Other
Intervention Name(s)
Wet-to-Dry Dressings
Intervention Description
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
Other
Intervention Name(s)
Petrolatum with Non-Stick Gauze
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Wound QOL Survey Score Over Time
Description
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.
Time Frame
Administered at 1, 2, 4 and 6 weeks post-surgery
Title
Change in PUSH Score Over Time
Description
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.
Time Frame
Completed at 1, 2, 4 and 6 weeks post-surgery utilizing images submitted by patients
Title
Change in Pain with Dressing Changes
Description
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.
Time Frame
Collected at 1, 2, 4 and 6 weeks post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher J Sayed, MD
Phone
(984) 974-3900
Email
christopher_sayed@med.unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Franklin R Blum, BS
Phone
(984) 974-3900
Email
franklin_blum@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J Sayed, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Franklin R Blum, BS
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC School of Medicine Department of Dermatology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher J Sayed, MD
Phone
984-974-3900
Email
christopher_sayed@med.unc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD Sharing Time Frame
Beginning 9 to 36 months following publication
IPD Sharing Access Criteria
Investigator who proposes to use the data has approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Citations:
PubMed Identifier
26470610
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.
Results Reference
background
PubMed Identifier
11305381
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.
Results Reference
background
PubMed Identifier
26521975
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.
Results Reference
background
PubMed Identifier
29094346
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.
Results Reference
background
PubMed Identifier
29080332
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.
Results Reference
background
PubMed Identifier
11723157
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.
Results Reference
background
PubMed Identifier
23860221
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.
Results Reference
background
PubMed Identifier
3345089
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.
Results Reference
background
Links:
URL
https://cdn-links.lww.com/permalink/jwocn/a/jwocn_38_4_2011_04_07_gardner_1_sdc1.pdf
Description
PUSH Tool
URL
https://www.daemen.edu/sites/default/files/Wound-Outcome-Measure-Questionnaire.pdf
Description
Wound QOL Survey

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

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