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临床试验/NCT03148496
NCT03148496终止不适用

Tissue Reinforcement of Incisional Closure Among High Risk Patients

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2017年9月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
163
试验地点
2
主要终点
Proportion of Participants Major Chronic Wound Infection

研究概览

简要总结

Half of all individuals will undergo abdominal surgery in their lifetime. Following abdominal surgery, 30% of patients will suffer a major chronic complication with their wound closure in the first post-operative year. This may include significant wound infections, open wounds, fluid collections, fascial dehiscence, or incisional hernia. These complications not only have a substantial impact on the health care system (cost and chronic disease) and the hospital (cost and space), but most importantly have a substantial impact on the patient. Major chronic wound complications adversely impact patient quality of life and function. Potential methods to reduce major wound complications include utilizing specific suturing techniques or reinforcing the incision line. Suturing technique of small-bites (0.5x0.5 cm bites) as opposed to large bites (1.0x1.0 cm bites) has been shown to be efficacious in European populations with a typical body mass index of 20-25 kg/m2. Tissue reinforcement has been shown to decrease rates of major wound complications in small randomized controlled trials.

However, the lack of widespread adoption of these practices may be due to issues of generalizability including strict inclusion criteria, careful patient selection, and small study size. For example, the generalizability of small bites to an overweight population (mean BMI in the United States is 28 kg/m2) as opposed to a normal-weight population are unclear. The use of synthetic materials in comorbid patients or complex settings may risk major wound complications such as prosthetic infection. Biologic materials have been shown to be effective in decreasing major wound complications but in different settings. This study is being done to assess the effectiveness of different efficacious strategies to decrease the rate of major wound complications following abdominal surgery among high-risk individuals The researchers hypothesize:

  1. Among high-risk patients undergoing abdominal surgery, the use of "small-bites" closure as opposed to "large-bites" closure will increase the proportion of patients who are free of major, chronic wound complications at 1-year post-operative.
  2. Among high-risk patients undergoing abdominal surgery, the biologic tissue reinforcement of the suture line as opposed to no reinforcement will increase the proportion of patients who are free of major, chronic wound complications at 1-year post-operative.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

  • •All high-risk patients undergoing laparotomy or laparoscopic-assisted abdominal surgery. This includes:
  • •all overweight patients (BMI>=25 kg/m2),
  • •current smokers,
  • •those who are immunosuppressed,
  • •those who are malnourished, or
  • •those who are undergoing a contaminated case (CDC wound classification of 2 or 3).

排除标准

  • •patients unlikely to follow-up in a year (e.g. no phone or lives out of state),
  • •patients unlikely to survive more than 2 years based upon surgeon judgment (e.g. metastatic cancer, end-stage cirrhosis),
  • •patients where the clinician would not place prosthetic (e.g. pregnant patient, pediatric patient during growth stage),
  • •patient has a planned second surgery within the next year (e.g. ostomy reversal).

研究组 & 干预措施

Biologic Mesh and Small Bites

Experimental

Biologic mesh placement and small bites used for suturing.

干预措施: Biologic Mesh (Device)

Biologic Mesh and Small Bites

Experimental

Biologic mesh placement and small bites used for suturing.

干预措施: Small Bites (Procedure)

Small Bites and No Biologic Mesh

Experimental

Small bites used for suturing with no placement of biologic mesh

干预措施: Small Bites (Procedure)

Biologic mesh and Large Bites

Experimental

Biologic mesh placement and large bites used for suturing

干预措施: Biologic Mesh (Device)

Biologic mesh and Large Bites

Experimental

Biologic mesh placement and large bites used for suturing

干预措施: Large Bites (Procedure)

Large Bites and no biologic mesh

Active Comparator

Large bites used for suturing and no placement of biologic mesh.

干预措施: Large Bites (Procedure)

结局指标

主要结局

Proportion of Participants Major Chronic Wound Infection

时间窗: 1 year after surgery

Proportion of participants with major chronic wound infection

次要结局

  • Number of Participants With Surgical Site Infections(3 years after surgery)
  • Surgeon Perception(3 years after surgery)
  • Participants Health Status as Assessed by the Euroqol-5D Questionnaire(3 years after surgery)
  • Cost Analyses(3 years after surgery)
  • Number of Participants With Major Complications(3 years after surgery)
  • Operative Duration(about 119 minutes to 337 minutes)
  • Number of Participants With Reoperations(3 years after surgery)
  • Participants Quality of Life as Assessed by Activities Assessment Scale(3 years after surgery)
  • Number of Participants With Major Complications(1 year after surgery)
  • Number of Participants With Surgical Site Infections(1 year after surgery)
  • Number of Participants With Reoperations(1 year after surgery)
  • Participants Quality of Life as Assessed by Activities Assessment Scale(1 year after surgery)
  • Participants Health Status as Assessed by the Euroqol-5D Questionnaire(1 year after surgery)
  • Cost Analyses(1 year after surgery)
  • Surgeon Perception(1 year after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julie Holihan

Assistant Professor of Surgery-Clinical

The University of Texas Health Science Center, Houston

研究点 (2)

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