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NCT Number: NCT07274878

Interrupted vs Subcuticular Sutures With Drain in Open Appendectomy

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.

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Key information

Conditions

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Current WHO guidelines on SSI prevention do not recommend a universal closure technique or routine subcutaneous drains, highlighting the need for targeted evidence.

Thus, the comparative effectiveness of simple interrupted sutures versus subcuticular closure combined with a subcutaneous drain in open appendectomy remains unclear, justifying a randomized controlled trial to address this gap.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

subcuticular suture plus subcutaneous drain

Procedure

Subcuticular suture plus subcutaneous drain uses a continuous absorbable subcuticular stitch combined with a drain placed in the subcutaneous layer to reduce dead space and fluid collection-offering both cosmetic closure and added infection-prevention compared with standard skin-only techniques.

Primary outcomes

  1. Incidence of superficial surgical-site infection (SSI)

    Time frame: 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).

Secondary outcomes

  1. Incidence of other wound-related complications

    Time frame: 30 days

    • Seroma or subcutaneous abscess formation.
    • Wound dehiscence (partial or complete).
    • Drain-site infection or complications
  2. Postoperative pain

    Time frame: at 24 hours, 48 hours, and 7-10days

    measured using the Visual Analogue Scale (VAS, 0-10 cm)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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