Trial Outcomes & Findings for Wet-to-dry vs Petrolatum & Non-stick Dressings After Hidradenitis Suppurativa Surgery (NCT NCT05194969)
NCT ID: NCT05194969
Last Updated: 2025-02-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
74 participants
Primary outcome timeframe
Administered at 1, 2, 4 and 6 weeks post-surgery
Results posted on
2025-02-18
Participant Flow
Participant milestones
| Measure |
Wet-to-dry Dressings
Participants in this arm will receive standard of care wet-to-dry dressings.
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
Participants in this arm will receive petrolatum with non-stick gauze.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
35
|
|
Overall Study
COMPLETED
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
12
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wet-to-dry vs Petrolatum & Non-stick Dressings After Hidradenitis Suppurativa Surgery
Baseline characteristics by cohort
| Measure |
Wet-to-dry Dressings
n=39 Participants
Participants in this arm will receive standard of care wet-to-dry dressings.
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
n=35 Participants
Participants in this arm will receive petrolatum with non-stick gauze.
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.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
34.8 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
37.8 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
37.6 kg/m^2
n=5 Participants
|
37.0 kg/m^2
n=7 Participants
|
37.3 kg/m^2
n=5 Participants
|
|
Smoking History
Current Smoker
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Smoking History
Former Smoker
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Smoking History
Never Smoker
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Hurley Stage
Hurley I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Hurley Stage
Hurley II
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Hurley Stage
Hurley III
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Hurley Stage
Hurley Unreported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Administered at 1, 2, 4 and 6 weeks post-surgeryPopulation: All available data are reported. Unreported data are for those lost to follow-up.
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.
Outcome measures
| Measure |
Wet-to-dry Dressings
n=33 Participants
Participants in this arm will receive standard of care wet-to-dry dressings.
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
n=30 Participants
Participants in this arm will receive petrolatum with non-stick gauze.
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.
|
|---|---|---|
|
Wound QOL Survey Score Over Time
Week 1
|
1.14 score on a scale
Interval 0.1 to 3.1
|
0.94 score on a scale
Interval 0.0 to 3.3
|
|
Wound QOL Survey Score Over Time
Week 2
|
0.77 score on a scale
Interval 0.0 to 3.5
|
0.66 score on a scale
Interval 0.0 to 2.6
|
|
Wound QOL Survey Score Over Time
Week 4
|
0.51 score on a scale
Interval 0.0 to 1.9
|
0.54 score on a scale
Interval 0.0 to 2.6
|
|
Wound QOL Survey Score Over Time
Week 6
|
0.28 score on a scale
Interval 0.0 to 0.9
|
0.42 score on a scale
Interval 0.0 to 2.9
|
PRIMARY outcome
Timeframe: Completed at 1, 2, 4 and 6 weeks post-surgery utilizing images submitted by patientsPopulation: All available data are reported. Unreported data are for those lost to follow-up.
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.
Outcome measures
| Measure |
Wet-to-dry Dressings
n=24 Participants
Participants in this arm will receive standard of care wet-to-dry dressings.
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
n=21 Participants
Participants in this arm will receive petrolatum with non-stick gauze.
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.
|
|---|---|---|
|
PUSH Score Over Time
Week 1
|
11.0 score on a scale
Interval 5.0 to 15.0
|
11.4 score on a scale
Interval 5.0 to 14.0
|
|
PUSH Score Over Time
Week 2
|
9.1 score on a scale
Interval 0.0 to 14.0
|
10.0 score on a scale
Interval 4.0 to 14.0
|
|
PUSH Score Over Time
Week 4
|
5.7 score on a scale
Interval 0.0 to 13.0
|
6.2 score on a scale
Interval 0.0 to 12.0
|
|
PUSH Score Over Time
Week 6
|
3.9 score on a scale
Interval 0.0 to 11.0
|
2.7 score on a scale
Interval 0.0 to 8.0
|
PRIMARY outcome
Timeframe: Collected at 1, 2, 4 and 6 weeks post-surgeryPopulation: All available data are reported. Unreported data are for those lost to follow-up.
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.
Outcome measures
| Measure |
Wet-to-dry Dressings
n=33 Participants
Participants in this arm will receive standard of care wet-to-dry dressings.
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
n=30 Participants
Participants in this arm will receive petrolatum with non-stick gauze.
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.
|
|---|---|---|
|
Pain With Dressing Changes Over Time
Week 1 Pain with Dressing Removal
|
6.2 score on a scale
Interval 0.0 to 10.0
|
3.6 score on a scale
Interval 0.0 to 10.0
|
|
Pain With Dressing Changes Over Time
Week 2 Pain with Dressing Removal
|
3.5 score on a scale
Interval 0.0 to 10.0
|
2.3 score on a scale
Interval 0.0 to 8.0
|
|
Pain With Dressing Changes Over Time
Week 4 Pain with Dressing Removal
|
2.1 score on a scale
Interval 0.0 to 10.0
|
1.6 score on a scale
Interval 0.0 to 7.0
|
|
Pain With Dressing Changes Over Time
Week 6 Pain with Dressing Removal
|
1.4 score on a scale
Interval 0.0 to 10.0
|
1.1 score on a scale
Interval 0.0 to 8.0
|
|
Pain With Dressing Changes Over Time
Week 1 Pain with Dressing Application
|
3.0 score on a scale
Interval 0.0 to 8.0
|
2.1 score on a scale
Interval 0.0 to 7.0
|
|
Pain With Dressing Changes Over Time
Week 2 Pain with Dressing Application
|
2.2 score on a scale
Interval 0.0 to 7.0
|
1.3 score on a scale
Interval 0.0 to 6.0
|
|
Pain With Dressing Changes Over Time
Week 4 Pain with Dressing Application
|
1.2 score on a scale
Interval 0.0 to 7.0
|
1.0 score on a scale
Interval 0.0 to 6.0
|
|
Pain With Dressing Changes Over Time
Week 6 Pain with Dressing Application
|
0.5 score on a scale
Interval 0.0 to 7.0
|
0.7 score on a scale
Interval 0.0 to 6.0
|
Adverse Events
Wet-to-dry Dressings
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Petrolatum With Non-Stick Gauze
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Wet-to-dry Dressings
n=39 participants at risk
Participants in this arm will receive standard of care wet-to-dry dressings.
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
n=35 participants at risk
Participants in this arm will receive petrolatum with non-stick gauze.
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Prolonged bleeding during dressing changes
|
2.6%
1/39 • Number of events 1 • From the time of signing informed consent through 6 weeks post-surgery.
|
0.00%
0/35 • From the time of signing informed consent through 6 weeks post-surgery.
|
Additional Information
Christopher J. Sayed, MD
University of North Carolina at Chapel Hill
Phone: 984-974-3900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place