Interrupted vs Subcuticular Sutures With Drain in Open Appendectomy

NCT07274878 | Not Yet Recruiting

• 1 other identifier: IVSSDOART
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary aim of this study is to compare wound outcomes between two closure strategies after open appendectomy:

• 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.

Conditions

Sutures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of other wound-related complications

  30 days

• Postoperative pain

  at 24 hours, 48 hours, and 7-10days

Study Arms (1)

subcuticular suture plus subcutaneous drain

EXPERIMENTAL

Procedure: subcuticular suture plus subcutaneous drain

Interventions

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.

subcuticular suture plus subcutaneous drain

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• 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 RESULT

• 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.

  PMID: 27816413 RESULT

• 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.

  PMID: 38222020 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Docter

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 10, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12