Hidradenitis SuppurativaNCT05194969
Wet-to-dry vs Petrolatum & Non-stick Dressings After Hidradenitis Suppurativa Surgery
A study testing Wet-to-Dry Dressings and Petrolatum with Non-Stick Gauze in people with Hidradenitis Suppurativa and Surgical Wound, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Hidradenitis Suppurativa, Surgical Wound
- What is being tested?
- Wet-to-Dry Dressings and Petrolatum with Non-Stick Gauze
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC School of Medicine Department of Dermatology
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
- Conditions
- Hidradenitis Suppurativa, Surgical Wound
- Being tested
- Wet-to-Dry Dressings, Petrolatum with Non-Stick Gauze
- Medical subject headings
- Hidradenitis Suppurativa, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wet-to-Dry DressingsDevice
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 GauzeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Wet-to-dry Dressings | Active comparator | Participants in this arm will receive standard of care wet-to-dry dressings. Receives: Device: Wet-to-Dry Dressings |
| Petrolatum with Non-Stick Gauze | Experimental | Participants in this arm will receive petrolatum with non-stick gauze. Receives: Device: Petrolatum with Non-Stick Gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. A mean score is calculated using each component such that a total score ranges from 0 to 4 with higher scores indicating a worse outcome.
Measured: Administered at 1, 2, 4 and 6 weeks post-surgery
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.
Measured: Completed at 1, 2, 4 and 6 weeks post-surgery utilizing images submitted by patients
Pain With Dressing Changes Over Time
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.
Measured: Collected at 1, 2, 4 and 6 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start25 Apr 2022
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Christopher J Sayed, MD, Study director, University of North Carolina, Chapel HillFranklin R Blum, BS, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194969
- Sponsor's protocol ID
- 21-1989
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2022
- Last updated
- 18 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 26470610von 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.
PubMed 11305381Ring 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.
PubMed 26521975Ingram 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.
PubMed 29094346Augustin 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.
PubMed 29080332Stotts 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.
PubMed 11723157Thompson 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.
PubMed 23860221Eaglstein 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.
PubMed 3345089
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Wet-to-dry vs Petrolatum and Non-stick Dressing for Second Intention Healing Following Hidradenitis Suppurativa Surgery
- ClinicalTrials.gov ID
- NCT05194969
- Acronym / sponsor ID
- 21-1989
- Conditions
- Hidradenitis Suppurativa, Surgical Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Posted 28 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Wet-to-dry Dressings | Active comparator | Device: Wet-to-Dry DressingsParticipants in this arm will receive standard of care wet-to-dry dressings. |
| Petrolatum with Non-Stick Gauze | Experimental | Device: Petrolatum with Non-Stick GauzeParticipants in this arm will receive petrolatum with non-stick gauze. |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wet-to-Dry DressingsThis 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 | Device | Wet-to-dry Dressings |
| Petrolatum with Non-Stick GauzeThis 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. | Device | Petrolatum with Non-Stick Gauze |
Primary outcome
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. A mean score is calculated using each component such that a total score ranges from 0 to 4 with higher scores indicating a worse outcome.
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.
Pain With Dressing Changes Over Time
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26470610van 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.
- Background: PubMed 11305381von 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.
- Background: PubMed 26521975Ring 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.
- Background: PubMed 29094346Ingram 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.
- Background: PubMed 29080332Augustin 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.
- Background: PubMed 11723157Stotts 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.
- Background: PubMed 23860221Thompson 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.
- Background: PubMed 3345089Eaglstein 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.
- PUSH ToolLink provided by the sponsor.
- Wound QOL SurveyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Sayed, MD study director
University of North Carolina, Chapel Hill
Franklin R Blum, BS principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wet-to-Dry Dressings and Petrolatum with Non-Stick Gauze in people with Hidradenitis Suppurativa and Surgical Wound, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound QOL Survey Score Over Time (time frame: Administered at 1, 2, 4 and 6 weeks post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05194969, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.