Suture Repair of Lacerations in the Emergency Department: Comparison Between Absorbable and Non-absorbable Suture Material
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Score in Wound Healing From Surgery to 2 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Patient Portion
研究概览
简要总结
This study aims to determine whether the use of non-absorbable (i.e. nylon) versus absorbable (i.e. chromic gut) sutures in traumatic hand lacerations affects wound healing, patient perception, and development of complications.
详细描述
There has been limited data published on suture type in traumatic hand wounds. The only study we found in our literature review was a retrospective study comparing vicryl vs. nylon suture and found no difference in scar appearance, tenderness, retraction, or complications as far as 6 months after repair (2). There have been no prospective studies on this topic. The theoretical advantage of absorbable suture for these wounds is they do not require suture removal, thereby removing the discomfort of suture removal as well potentially decreasing the burden of follow-up.
At the Penn State Health Hershey Medical Center, either suture choice included in this study is considered standard of care and is routinely used. Selection as to whether absorbable or non-absorbable suture is used is based on the preference and discretion of the resident and attending surgeon involved in the patient care. As such, if a patient were to present to the emergency department with a forearm or hand laceration and hand surgery were consulted, regardless of whether the patient opts to participate in this research study, their laceration would be repaired with either absorbable or non-absorbable suture depending on provider preference and the patient would be scheduled follow-up.
There have been multiple prospective clinical trials on suture type in the context of planned surgical incisions, specifically carpal tunnel release, with variable outcomes. One clinical trial looking at a total of 40 incisions found no difference in pain, tenderness, inflammation, or outcomes postoperatively (3). Certain clinical trials favored non-absorbable sutures, reporting a higher rate of infection (4) or inflammation (5) with vicryl suture as compared to non-braided, non-absorbable sutures. On the other hand, other clinical trials favored absorbable sutures, describing reduction in pain scores (6) and pain associated with absorbable suture removal in the setting of other equivalent outcomes (7).
The purpose of the study is to evaluate the use of absorbable and non-absorbable suture material in hand lacerations repaired in the Penn State Health Milton S. Hershey Emergency Department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking. Both participant and care providers will know group assignment
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
- •Subject seen in PSHMC Emergency Department for hand or forearm lacerations (i.e. laceration below the level of the elbow) that require suture repair, in which Hand Surgery is consulted
- •CDC surgical wound classification grades I-IV
- •Age >18 years of age
- •Gender: male or female (non-pregnant)
- •Fluent in written and spoken English
- •Subject is able to provide voluntary, written informed consent
- •Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits
- •Non-Prisoners
排除标准
- •Known allergy to suture material
- •History of immunosuppression (i.e. concurrent chemotherapy, steroid use or immunomodulatory therapy)
- •History of diabetes mellitus
- •Pregnancy
- •Current Tobacco use
- •Age < 18 years old
- •Previous skin laceration at same location
- •History of previous hypertrophic or keloid scar
- •Concurrent tendon, nerve or bone injury requiring trip to the operating room
- •Non-English speaking patients
- •Cognitive impairment
- •Prisoners
研究组 & 干预措施
Absorbable Surgical Gut Suture
Ethicon Chromic Surgical Gut Suture Is an absorbable, sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) Intestines. Surgical Gut Suture is Indicated for use In general soft tissue approximation and/or ligation, including use In ophthalmic procedures, but not for use in cardiovascular and neurologic tissues.
干预措施: Absorbable Surgical Gut Suture material (Device)
Non-absorbable Nylon Suture
Ethicon ETHILON* nylon suture is a nonabsorbab\e, sterile surgical monofi\ament suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. ETHILON sutures are dyed black or green to enhance visibility in tissue. The suture is also available undyed (clear). ETHILON suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
干预措施: Non-absorbable Nylon Suture Material (Device)
结局指标
主要结局
Score in Wound Healing From Surgery to 2 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Patient Portion
时间窗: 2 weeks post-laceration repair
Patients return to the practice site at 2 weeks, 6 weeks, and 12 weeks after their initial visit to the Emergency Department and complete the Patient and Observer Scar Assessment Scale (POSAS). The assigned blinded observer also completes this survey. Scores are obtained from both the subject and observer at 2 weeks, 6 weeks, and 12 weeks. The Patient and Observer Scar Assessment Scale (POSAS) evaluates scars and consists of two 6-item, 10-point scales (1 = normal skin, 10 = worst scar imaginable) for both patients and observers. Scores for each scale range from 6 to 60, where higher scores indicate poorer scar quality. Both scales include an overall opinion item, which is not included in the sum score.
Score in Wound Healing From Surgery 6 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Patient Portion
时间窗: 6 weeks post-laceration repair
Patients return to the practice site at 2 weeks, 6 weeks, and 12 weeks after their initial visit to the Emergency Department and complete the Patient and Observer Scar Assessment Scale (POSAS). The assigned blinded observer also completes this survey. Scores are obtained from both the subject and observer at 2 weeks, 6 weeks, and 12 weeks. The Patient and Observer Scar Assessment Scale (POSAS) evaluates scars and consists of two 6-item, 10-point scales (1 = normal skin, 10 = worst scar imaginable) for both patients and observers. Scores for each scale range from 6 to 60, where higher scores indicate poorer scar quality. Both scales include an overall opinion item, which is not included in the sum score.
Score in Wound Healing From Surgery 12 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Patient Portion
时间窗: 12 weeks post-laceration repair
Patients return to the practice site at 2 weeks, 6 weeks, and 12 weeks after their initial visit to the Emergency Department and complete the Patient and Observer Scar Assessment Scale (POSAS). The assigned blinded observer also completes this survey. Scores are obtained from both the subject and observer at 2 weeks, 6 weeks, and 12 weeks. The Patient and Observer Scar Assessment Scale (POSAS) evaluates scars and consists of two 6-item, 10-point scales (1 = normal skin, 10 = worst scar imaginable) for both patients and observers. Scores for each scale range from 6 to 60, where higher scores indicate poorer scar quality. Both scales include an overall opinion item, which is not included in the sum score.
Score in Wound Healing From Surgery to 2 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Observer Portion
时间窗: 2 weeks post-laceration repair
Patients return to the practice site at 2 weeks, 6 weeks, and 12 weeks after their initial visit to the Emergency Department and complete the Patient and Observer Scar Assessment Scale (POSAS). The assigned blinded observer also completes this survey. Scores are obtained from both the subject and observer at 2 weeks, 6 weeks, and 12 weeks. The Patient and Observer Scar Assessment Scale (POSAS) evaluates scars and consists of two 6-item, 10-point scales (1 = normal skin, 10 = worst scar imaginable) for both patients and observers. Scores for each scale range from 6 to 60, where higher scores indicate poorer scar quality. Both scales include an overall opinion item, which is not included in the sum score.
Score in Wound Healing From Surgery 6 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Observer Portion
时间窗: 6 weeks post-laceration repair
Patients return to the practice site at 2 weeks, 6 weeks, and 12 weeks after their initial visit to the Emergency Department and complete the Patient and Observer Scar Assessment Scale (POSAS). The assigned blinded observer also completes this survey. Scores are obtained from both the subject and observer at 2 weeks, 6 weeks, and 12 weeks. The Patient and Observer Scar Assessment Scale (POSAS) evaluates scars and consists of two 6-item, 10-point scales (1 = normal skin, 10 = worst scar imaginable) for both patients and observers. Scores for each scale range from 6 to 60, where higher scores indicate poorer scar quality. Both scales include an overall opinion item, which is not included in the sum score.
Score in Wound Healing From Surgery 12 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Observer Portion
时间窗: 12 weeks post-laceration repair
Patients return to the practice site at 2 weeks, 6 weeks, and 12 weeks after their initial visit to the Emergency Department and complete the Patient and Observer Scar Assessment Scale (POSAS). The assigned blinded observer also completes this survey. Scores are obtained from both the subject and observer at 2 weeks, 6 weeks, and 12 weeks. The Patient and Observer Scar Assessment Scale (POSAS) evaluates scars and consists of two 6-item, 10-point scales (1 = normal skin, 10 = worst scar imaginable) for both patients and observers. Scores for each scale range from 6 to 60, where higher scores indicate poorer scar quality. Both scales include an overall opinion item, which is not included in the sum score.
次要结局
- Patient Reported Pain Using the Visual Analog Scale (VAS) at 2-weeks(2 weeks post-laceration repair)
- Patient Reported Pain Using the Visual Analog Scale (VAS) at 6-weeks(6 weeks post-laceration repair)
- Patient Reported Pain Using the Visual Analog Scale (VAS) at 12-weeks(12 weeks post-laceration repair)
研究者
Kenneth Taylor, M.D.
Professor of Orthopaedics and Rehabilitation
Milton S. Hershey Medical Center