Aesthetic Outcome of Tie-over Bolster Application in Surgical Wounds: a Randomized Evaluator-blinded Split-wound Comparative Effectiveness Trial.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
研究概览
简要总结
When patients have surgery on the head and face, stitches are the standard way to close the wound. Wounds always result in a scar, but doctors are always looking for ways to reduce scarring. Several studies have been done to test ways to close wounds that reduce scarring. One idea is to reduce the tension around the cut. One way to reduce tension is to stitch a small piece of a special gauze over the top of the regular stitches. This procedure is called a "tie-over bolster dressing." As the name implies, this extra dressing "bolsters" the wound closure so that the skin on each side of the cut stays in place.
The bolster dressing procedure has been used in the past in special cases, such as when skin grafts are necessary. The bolster dressing helps the skin graft heal by making sure the graft stays exactly in place. Keeping the wound stable with a bolster dressing also reduces bleeding under the wound. For non-grafted wounds, the bolster dressing procedure has not normally been used, and has not been well-studied. In this study the whole wound will be stitched normally and then the bolster dressing will be applied over half of the wound. This will allow us to see if the side with the bolster dressing heals with less scarring.
详细描述
Following cutaneous surgical procedures, scar formation is inevitable. Reducing the degree of scar formation and achieving the best aesthetic outcome remains prominent within the dermatological literature. Recent research has highlighted the impact of mechanical forces and tension on scar formation, demonstrating that reducing the mechanical stress within the wound environment results in better aesthetic outcome (1,2). Tension-shielding devices have shown promise in scar reduction in both humans and porcine models (2). More recently, two clinical trials have shown that the use of an "embrace" device, a silicone-based dressing designed to minimize wound tension, effectively improves the aesthetic outcome following scar revision surgery (3,4). In addition, application of negative pressure via vacuum sealing drainage (VSD), commonly called a "wound-vac", has been consistently shown to accelerate wound healing (5). However, using these methods can be challenging, particularly due to cost, practicability, and patient compliance.
An alternative method for reducing mechanical stressors along scars has long been used within dermatologic surgery, namely the application of a bolster dressing.
For decades, tie-over bolster dressings have been employed following cutaneous procedures repaired with skin grafting. Typically, these bolsters are composed of Xeroform gauze (bismuth tribromophenate petrolatum-impregnated gauze) which are sutured on top of the graft. These have been shown to stabilize the graft, immobilize the wound bed, and reduce hematoma formation by delivering persistent downward pressure (6,7).
To our knowledge, the impact of scar cosmesis and rate of post-operative complications following the administration of tie-over bolster dressing over primary linear repair of surgical wounds have not been studied. This study seeks to determine the effectiveness of a tie-over bolster dressing in reducing tension to improve scar cosmesis by using individuals as their own controls in a split-scar model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Two blinded observers will record their scores independently using the POSAS instrument.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Able to give informed consent themselves
- •Patient scheduled for cutaneous surgical procedure on the head or neck with predicted primary closure
- •Willing to return for follow-up visit
排除标准
- •Incarceration
- •Under 18 years of age
- •Pregnant women
- •Unable to understand written and oral English Wounds with predicted closure length less than 3cm
研究组 & 干预措施
Layered Closure
A cutaneous layer of sutures will be placed on one side of wound, as is standard of care.
Layered Closure with Tie-Over Bolster Dressing
The other side of wound will have a cutaneous layer of sutures with the addition of a bolster dressing.
干预措施: Addition of Tie-Over Bolster Dressing (Procedure)
结局指标
主要结局
Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
时间窗: 3 months
The primary endpoint will be the score of two blinded reviewers independently using the POSAS assessment. The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability, and surface area). All items are scored on a scale ranging from 1 ("like normal skin") to 10 ("worst scar imaginable"). The sum of the six items results in a total score of the POSAS observer scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location.
次要结局
- Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)(3 months)
- Width of Scar as measured using Trace-to-Tape Method(3 months)
- Complications or Adverse Events from Treatment(3 months)