Interrupted vs Subcuticular Sutures With Drain in Open Appendectomy

Official title

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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Incidence of superficial surgical-site infection (SSI) [Time frame: 30 days]

Secondary outcome measures (2)

• Incidence of other wound-related complications [Time frame: 30 days]
• Postoperative pain [Time frame: at 24 hours, 48 hours, and 7-10days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 32075838
• 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 PMID 27816413
• 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. PMID 38222020
• 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. PMID 27283187
• 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. PMID 27699563
• 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. PMID 26460662

Identifiers

NCT: NCT07274878 · IVSSDOART

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗