Interrupted vs Subcuticular Sutures With Drain in Open Appendectomy

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sutures
• Intervention / Treatment: Procedure: subcuticular suture plus subcutaneous drain

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: subcuticular suture plus subcutaneous drain	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of superficial surgical-site infection (SSI)	Incidence of superficial surgical-site infection (SSI) after open appendectomy, defined according to CDC/NHSN criteria (purulent drainage, positive culture, or surgeon diagnosis).	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of other wound-related complications	Seroma or subcutaneous abscess formation.; Wound dehiscence (partial or complete).; Drain-site infection or complications	30 days
Postoperative pain	measured using the Visual Analogue Scale (VAS, 0-10 cm)	at 24 hours, 48 hours, and 7-10days

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Danwang C, Bigna JJ, Tochie JN, Mbonda A, Mbanga CM, Nzalie RNT, Guifo ML, Essomba A. Global incidence of surgical site infection after appendectomy: a systematic review and meta-analysis. BMJ Open. 2020 Feb 18;10(2):e034266. doi: 10.1136/bmjopen-2019-034266.
• Allegranzi B, Bischoff P, de Jonge S, Kubilay NZ, Zayed B, Gomes SM, Abbas M, Atema JJ, Gans S, van Rijen M, Boermeester MA, Egger M, Kluytmans J, Pittet D, Solomkin JS; WHO Guidelines Development Group. New WHO recommendations on preoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis. 2016 Dec;16(12):e276-e287. doi: 10.1016/S1473-3099(16)30398-X. Epub 2016 Nov 2.
• Ishinuki T, Shinkawa H, Kouzu K, Shinji S, Goda E, Ohyanagi T, Kobayashi M, Kobayashi M, Suzuki K, Kitagawa Y, Yamashita C, Mohri Y, Shimizu J, Uchino M, Haji S, Yoshida M, Ohge H, Mayumi T, Mizuguchi T. Recent evidence for subcutaneous drains to prevent surgical site infections after abdominal surgery: A systematic review and meta-analysis. World J Gastrointest Surg. 2023 Dec 27;15(12):2879-2889. doi: 10.4240/wjgs.v15.i12.2879.
• Andrade LA, Munoz FY, Baez MV, Collazos SS, de Los Angeles Martinez Ferretiz M, Ruiz B, Montes O, Woolf S, Noriega JG, Aparicio UM, Gonzalez IG. Appendectomy Skin Closure Technique, Randomized Controlled Trial: Changing Paradigms (ASC). World J Surg. 2016 Nov;40(11):2603-2610. doi: 10.1007/s00268-016-3607-x.
• Imamura K, Adachi K, Sasaki R, Monma S, Shioiri S, Seyama Y, Miura M, Morikawa Y, Kaneko T. Randomized Comparison of Subcuticular Sutures Versus Staples for Skin Closure After Open Abdominal Surgery: a Multicenter Open-Label Randomized Controlled Trial. J Gastrointest Surg. 2016 Dec;20(12):2083-2092. doi: 10.1007/s11605-016-3283-z. Epub 2016 Oct 3.
• Bhangu A, Soreide K, Di Saverio S, Assarsson JH, Drake FT. Acute appendicitis: modern understanding of pathogenesis, diagnosis, and management. Lancet. 2015 Sep 26;386(10000):1278-1287. doi: 10.1016/S0140-6736(15)00275-5.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IVSSDOART

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No