Interrupted vs Subcuticular Sutures With Drain in Open Appendectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-01-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Sutures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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subcuticular suture plus subcutaneous drain

Group Type EXPERIMENTAL

subcuticular suture plus subcutaneous drain

Intervention Type 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.

Interventions

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subcuticular suture plus subcutaneous drain

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No