Hidradenitis Suppurativa, Surgical Wound
Conditions
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.
Interventions
DEVICEWet-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
DEVICEPetrolatum 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.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
16 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound QOL Survey Score Over Time | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 39 |
| 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. | 35 |
| Total | 74 |
Baseline characteristics
| Characteristic | Wet-to-dry Dressings | Petrolatum With Non-Stick Gauze | Total |
|---|---|---|---|
| Age, Continuous | 40.5 years STANDARD_DEVIATION 14.5 | 34.8 years STANDARD_DEVIATION 9.5 | 37.8 years STANDARD_DEVIATION 11.9 |
| Body Mass Index (BMI) | 37.6 kg/m^2 | 37.0 kg/m^2 | 37.3 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 34 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hurley Stage Hurley I | 0 Participants | 0 Participants | 0 Participants |
| Hurley Stage Hurley II | 26 Participants | 22 Participants | 48 Participants |
| Hurley Stage Hurley III | 13 Participants | 12 Participants | 25 Participants |
| Hurley Stage Hurley Unreported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 24 Participants | 42 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) White | 16 Participants | 10 Participants | 26 Participants |
| Region of Enrollment United States | 39 Participants | 35 Participants | 74 Participants |
| Sex: Female, Male Female | 31 Participants | 26 Participants | 57 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
| Smoking History Current Smoker | 5 Participants | 2 Participants | 7 Participants |
| Smoking History Former Smoker | 6 Participants | 7 Participants | 13 Participants |
| Smoking History Never Smoker | 28 Participants | 26 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 35 |
| other Total, other adverse events | 1 / 39 | 0 / 35 |
| serious Total, serious adverse events | 0 / 39 | 0 / 35 |
Outcome results
Primary
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.
Time frame: Collected at 1, 2, 4 and 6 weeks post-surgery
Population: All available data are reported. Unreported data are for those lost to follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Wet-to-dry Dressings | Pain With Dressing Changes Over Time | Week 1 Pain with Dressing Removal | 6.2 score on a scale |
| Wet-to-dry Dressings | Pain With Dressing Changes Over Time | Week 2 Pain with Dressing Removal | 3.5 score on a scale |
| Wet-to-dry Dressings | Pain With Dressing Changes Over Time | Week 4 Pain with Dressing Removal | 2.1 score on a scale |
| Wet-to-dry Dressings | Pain With Dressing Changes Over Time | Week 6 Pain with Dressing Removal | 1.4 score on a scale |
| Wet-to-dry Dressings | Pain With Dressing Changes Over Time | Week 1 Pain with Dressing Application | 3.0 score on a scale |
| Wet-to-dry Dressings | Pain With Dressing Changes Over Time | Week 2 Pain with Dressing Application | 2.2 score on a scale |
| Wet-to-dry Dressings | Pain With Dressing Changes Over Time | Week 4 Pain with Dressing Application | 1.2 score on a scale |
| Wet-to-dry Dressings | Pain With Dressing Changes Over Time | Week 6 Pain with Dressing Application | 0.5 score on a scale |
| Petrolatum With Non-Stick Gauze | Pain With Dressing Changes Over Time | Week 6 Pain with Dressing Application | 0.7 score on a scale |
| Petrolatum With Non-Stick Gauze | Pain With Dressing Changes Over Time | Week 1 Pain with Dressing Removal | 3.6 score on a scale |
| Petrolatum With Non-Stick Gauze | Pain With Dressing Changes Over Time | Week 1 Pain with Dressing Application | 2.1 score on a scale |
| Petrolatum With Non-Stick Gauze | Pain With Dressing Changes Over Time | Week 2 Pain with Dressing Removal | 2.3 score on a scale |
| Petrolatum With Non-Stick Gauze | Pain With Dressing Changes Over Time | Week 4 Pain with Dressing Application | 1.0 score on a scale |
| Petrolatum With Non-Stick Gauze | Pain With Dressing Changes Over Time | Week 4 Pain with Dressing Removal | 1.6 score on a scale |
| Petrolatum With Non-Stick Gauze | Pain With Dressing Changes Over Time | Week 2 Pain with Dressing Application | 1.3 score on a scale |
| Petrolatum With Non-Stick Gauze | Pain With Dressing Changes Over Time | Week 6 Pain with Dressing Removal | 1.1 score on a scale |
Primary
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.
Time frame: Completed at 1, 2, 4 and 6 weeks post-surgery utilizing images submitted by patients
Population: All available data are reported. Unreported data are for those lost to follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Wet-to-dry Dressings | PUSH Score Over Time | Week 1 | 11.0 score on a scale |
| Wet-to-dry Dressings | PUSH Score Over Time | Week 2 | 9.1 score on a scale |
| Wet-to-dry Dressings | PUSH Score Over Time | Week 4 | 5.7 score on a scale |
| Wet-to-dry Dressings | PUSH Score Over Time | Week 6 | 3.9 score on a scale |
| Petrolatum With Non-Stick Gauze | PUSH Score Over Time | Week 6 | 2.7 score on a scale |
| Petrolatum With Non-Stick Gauze | PUSH Score Over Time | Week 1 | 11.4 score on a scale |
| Petrolatum With Non-Stick Gauze | PUSH Score Over Time | Week 4 | 6.2 score on a scale |
| Petrolatum With Non-Stick Gauze | PUSH Score Over Time | Week 2 | 10.0 score on a scale |
Primary
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.
Time frame: Administered at 1, 2, 4 and 6 weeks post-surgery
Population: All available data are reported. Unreported data are for those lost to follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Wet-to-dry Dressings | Wound QOL Survey Score Over Time | Week 1 | 1.14 score on a scale |
| Wet-to-dry Dressings | Wound QOL Survey Score Over Time | Week 2 | 0.77 score on a scale |
| Wet-to-dry Dressings | Wound QOL Survey Score Over Time | Week 4 | 0.51 score on a scale |
| Wet-to-dry Dressings | Wound QOL Survey Score Over Time | Week 6 | 0.28 score on a scale |
| Petrolatum With Non-Stick Gauze | Wound QOL Survey Score Over Time | Week 6 | 0.42 score on a scale |
| Petrolatum With Non-Stick Gauze | Wound QOL Survey Score Over Time | Week 1 | 0.94 score on a scale |
| Petrolatum With Non-Stick Gauze | Wound QOL Survey Score Over Time | Week 4 | 0.54 score on a scale |
| Petrolatum With Non-Stick Gauze | Wound QOL Survey Score Over Time | Week 2 | 0.66 score on a scale |