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临床试验/NCT05194969
NCT05194969已完成不适用

Comparison of Wet-to-dry vs Petrolatum and Non-stick Dressing for Second Intention Healing Following Hidradenitis Suppurativa Surgery

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2022年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
2
主要终点
Pain With Dressing Changes Over Time

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
16 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Pain With Dressing Changes Over Time

时间窗: 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.

PUSH Score Over Time

时间窗: 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.

Wound QOL Survey Score Over Time

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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