- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05194969
Wet-to-dry vs Petrolatum & Non-stick Dressings After Hidradenitis Suppurativa Surgery
January 26, 2024 updated by: University of North Carolina, Chapel Hill
Comparison of Wet-to-dry vs Petrolatum and Non-stick Dressing for Second Intention Healing Following Hidradenitis Suppurativa Surgery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christopher J Sayed, MD
- Phone Number: (984) 974-3900
- Email: christopher_sayed@med.unc.edu
Study Contact Backup
- Name: Franklin R Blum, BS
- Phone Number: (984) 974-3900
- Email: franklin_blum@med.unc.edu
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- UNC School of Medicine Department of Dermatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Wet-to-dry Dressings
Participants in this arm will receive standard of care 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
|
Experimental: Petrolatum with Non-Stick Gauze
Participants in this arm will receive 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Wound QOL Survey Score Over Time
Time Frame: Administered at 1, 2, 4 and 6 weeks post-surgery
|
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
|
Change in PUSH Score Over Time
Time Frame: Completed at 1, 2, 4 and 6 weeks post-surgery utilizing images submitted by patients
|
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
|
Change in Pain with Dressing Changes
Time Frame: Collected at 1, 2, 4 and 6 weeks post-surgery
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Christopher J Sayed, MD, University of North Carolina, Chapel Hill
- Principal Investigator: Franklin R Blum, BS, University of North Carolina, Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2022
Primary Completion (Actual)
October 30, 2023
Study Completion (Actual)
October 30, 2023
Study Registration Dates
First Submitted
January 5, 2022
First Submitted That Met QC Criteria
January 5, 2022
First Posted (Actual)
January 18, 2022
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 26, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-1989
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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 and continuing for 36 months following publication
IPD Sharing Access Criteria
Investigator who proposes to use the data has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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