跳至主要内容
临床试验/NCT07274878
NCT07274878尚未招募不适用

Simple Interrupted Skin Sutures Versus Subcuticular Suture Plus Subcutaneous Drain for Wound Outcomes After Open Appendectomy

Assiut University0 个研究点目标入组 100 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Incidence of superficial surgical-site infection (SSI)

研究概览

简要总结

The primary aim of this study is to compare wound outcomes between two closure strategies after open appendectomy:

  1. Simple interrupted skin sutures (standard method), versus
  2. Subcuticular (intradermal) skin suture combined with a subcutaneous closed suction drain.

Specifically, the study aims to

  • Determine whether the combined subcuticular closure with drain reduces the incidence of superficial surgical- site infection (SSI) within 30 days compared with interrupted sutures.
  • Evaluate the effect of both techniques on secondary outcomes, including seroma or abscess formation, wound dehiscence, post-operative pain, cosmetic appearance of the scar, length of hospital stay, and drain-related adverse events.

详细描述

Open appendectomy remains a common emergency operation worldwide, particularly in settings where laparoscopic surgery is not feasible. Post-operative wound complications - especially superficial surgical-site infection (SSI), seroma and dehiscence - are frequent and lead to pain, longer hospital stay, antibiotic use and higher costs.

Reported SSI rates after appendectomy vary, but pooled global data suggest about 7 infections per 100 appendectomies, with higher rates generally seen after open procedures compared to laparoscopic approaches.

Skin closure technique is one modifiable factor influencing wound outcomes. Simple interrupted non-absorbable sutures are widely used, but continuous intradermal (subcuticular) absorbable sutures are increasingly studied. Randomized trials and systematic reviews show that subcuticular closure is at least as safe as interrupted closure regarding SSI, while often offering advantages such as improved cosmetic results, reduced need for suture removal, and lower patient discomfort.

A notable randomized trial in open appendectomy found fewer wound complications and better patient-reported outcomes with intradermal closure, though evidence across studies remains heterogeneous.

Placement of a subcutaneous closed suction drain is another potential strategy to reduce dead space and fluid collections, thereby lowering risks of seroma and infection. Meta-analyses suggest possible reductions in SSI and length of stay in abdominal surgery, but results are inconsistent and routine use remains controversial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Age ≥ 14 years (or per local ethics), undergoing open appendectomy for acute appendicitis (elective not included).
  • Skin incision for open appendectomy (McBurney/Gridiron or Lanz).
  • Patient (or legal guardian) able and willing to provide informed consent.

排除标准

  • Laparoscopic appendectomy or conversion to laparoscopic approach.
  • Previous abdominal surgery at the same site (risk of altered wound healing).
  • Pre-existing skin infection at the surgical site.

结局指标

主要结局

Incidence of superficial surgical-site infection (SSI)

时间窗: 30 days

Incidence of superficial surgical-site infection (SSI) after open appendectomy, defined according to CDC/NHSN criteria (purulent drainage, positive culture, or surgeon diagnosis).

次要结局

  • Incidence of other wound-related complications(30 days)
  • Postoperative pain(at 24 hours, 48 hours, and 7-10days)

研究者

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

Abdulrahman Rajab Abdulwahab Abdulwahab

Docter

Assiut University

相似试验