Ostomy Primary Closure With 0.1% Betaine/Polyhexanide Wound Irrigation Compared to Pursestring Closure

Summary

The goal of this clinical trial is to compare two types of closure in patients with ostomies that are ready for closure. The main questions it aims to answer are: 1. Surgical site infection rates 2. Patient quality of life 3. Time to wound healing Participants will undergo either complete ostomy wound closure after washing out the wound with Prontosan, or their ostomy wound will be closed using the Pursestring method, where the wound will be left partially open and allowed to heal from the inside out. Researchers will compare these two groups' outcomes (questions to be answered) as listed above.

Timeline

Start

2024-03-14

Primary completion

2028-12

Completion

2029-12

Publications

• Background van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
• Background Cooper DM, Bojke C, Ghosh P. Cost-Effectiveness of PHMB & betaine wound bed preparation compared with standard care in venous leg ulcers: A cost-utility analysis in the United Kingdom. J Tissue Viability. 2023 May;32(2):262-269. doi: 10.1016/j.jtv.2023.03.001. Epub 2023 Mar 16.
• Background Valenzuela AR, Perucho NS. [The effectiveness of a 0.1% polyhexanide gel]. Rev Enferm. 2008 Apr;31(4):7-12. Spanish.
• Background Siddiqi A, Abdo ZE, Springer BD, Chen AF. Pursuit of the ideal antiseptic irrigation solution in the management of periprosthetic joint infections. J Bone Jt Infect. 2021 May 26;6(6):189-198. doi: 10.5194/jbji-6-189-2021. eCollection 2021.
• Background Andriessen AE, Eberlein T. Assessment of a wound cleansing solution in the treatment of problem wounds. Wounds. 2008 Jun;20(6):171-5.
• Background Goztok M, Terzi MC, Egeli T, Arslan NC, Canda AE. Does Wound Irrigation with Clorhexidine Gluconate Reduce the Surgical Site Infection Rate in Closure of Temporary Loop Ileostomy? A Prospective Clinical Study. Surg Infect (Larchmt). 2018 Aug/Sep;19(6):634-639. doi: 10.1089/sur.2018.061. Epub 2018 Jul 24.
• Background Chang Z, Liu L, She C, Ren W, Chen H, Zhou C. A meta-analysis examined the effect of stoma on surgical site wound infection in colorectal cancer. Int Wound J. 2023 May;20(5):1578-1583. doi: 10.1111/iwj.14013. Epub 2022 Nov 19.
• Background Nyandoro MG, Seow YT, Stein J, Theophilus M. Single-centre experience of loop ileostomy closure: a retrospective comparison of conventional-linear closure and purse-string closure on surgical-site-infection rates. ANZ J Surg. 2023 Mar;93(3):629-635. doi: 10.1111/ans.18083. Epub 2022 Oct 5.
• Background Zhu Y, Chen J, Lin S, Xu D. Risk factor for the development of surgical site infection following ileostomy reversal: a single-center report. Updates Surg. 2022 Oct;74(5):1675-1682. doi: 10.1007/s13304-022-01335-0. Epub 2022 Aug 24.
• Background Turner MC, Migaly J. Surgical Site Infection: The Clinical and Economic Impact. Clin Colon Rectal Surg. 2019 May;32(3):157-165. doi: 10.1055/s-0038-1677002. Epub 2019 Apr 2.
• Background Wada Y, Miyoshi N, Ohue M, Noura S, Fujino S, Sugimura K, Akita H, Motoori M, Gotoh K, Takahashi H, Kobayashi S, Ohmori T, Fujiwara Y, Yano M. Comparison of surgical techniques for stoma closure: A retrospective study of purse-string skin closure versus conventional skin closure following ileostomy and colostomy reversal. Mol Clin Oncol. 2015 May;3(3):619-622. doi: 10.3892/mco.2015.505. Epub 2015 Feb 6.
• Background Yoon SI, Bae SM, Namgung H, Park DG. Clinical trial on the incidence of wound infection and patient satisfaction after stoma closure: comparison of two skin closure techniques. Ann Coloproctol. 2015 Feb;31(1):29-33. doi: 10.3393/ac.2015.31.1.29. Epub 2015 Feb 28.

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Indications