Interrupted vs Subcuticular Sutures With Drain in Open Appendectomy

Assiut University

Status: Not yet enrolling

Conditions: Sutures

Treatments: Procedure: subcuticular suture plus subcutaneous drain

Study type: Interventional

Funder types: Other

Identifiers

NCT07274878

IVSSDOART

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

subcuticular suture plus subcutaneous drain

Experimental group

Treatment:

Procedure: subcuticular suture plus subcutaneous drain