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

NCT06309368 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 003875
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. 1.Surgical site infection rates
2. 2.Patient quality of life
3. 3.Time to wound healing

Conditions

Surgical Site Infection; Wound Surgical; Colorectal Disorders

Keywords

Ostomy; Surgical Site Infection; Primary Closure; Secondary Closure

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection Rates

  Evaluate surgical site infection rates between the two treatment arms

  Evaluate surgical site for any signs of infection up to 30 days post-operatively.

Secondary Outcomes (5)

• Acceptability of wound or scar healing by patient

  Up to one year post-operatively.

• Amount of percepted wound care needed by patient

  Up to 4 weeks after compete wound closure.

• Acceptability of wound and scar healing by patient

  At 4 weeks post complete wound closure and at one year post-operatively.

• Wound healing

  Until complete wound closure (estimated up to 4-6 weeks post-operation).

• Acceptability of wound and scar healing by patient

  Up to one year post-operatively

Study Arms (2)

Primary Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation

ACTIVE COMPARATOR

The ostomy wound will be irrigated with 0.1% Betaine/0.1% Polyhexanide wound irrigation, then closed completely with sutures.

Drug: Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation

Secondary Closure with Pursestring

ACTIVE COMPARATOR

The ostomy wound will be partially closed using the Pursestring method.

Procedure: Pursestring Closure

Interventions

Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation DRUG

An elliptical transverse incision will be made extending 1-2 cm lateral and medial to the mucocutaneous junction. The mobilization, anastomosis and fascial closure will be performed as in the pursestring closure group. The incision will then be irrigated using direct stream into the wound with 350cc of Prontosan. After one minute the wound will be suctioned dry. The subcutaneous fat will be mobilized and approximated with interrupted 2-0 Vicryl. The skin will be approximated with deep dermal 3-0 Vicryl and a running subcuticular 4-0 Monocryl suture and Dermabond will be applied.

Also known as: Prontosan

Primary Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation

Pursestring Closure PROCEDURE

A circular incision will be made at the mucocutaneous junction of the ileostomy. After complete mobilization of the ileal limbs off the fascia and a stapled side to side functional end to end anastomosis, the fascia including the external and posterior rectus sheath will be closed with two running #0 PDS (Polydioxanone) suture. The wound will then be irrigated with saline and partially closed in the subcuticular plane with a 2-0 Monocryl suture in a pursestring fashion and packed in the middle with plain packing.

Secondary Closure with Pursestring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients 18 years or older with an diverting loop ileostomy reversal indication will be enrolled
• Signed consent

You may not qualify if:

• Under 18 years old, unable to provide consent, has a parastomal hernia requiring mesh repair, or has an end ileostomy

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

University Medical Center

Las Vegas, Nevada, 89102, United States

RECRUITING

Related Publications (12)

• 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.

  PMID: 16079683 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.

  PMID: 36990897 BACKGROUND

• Valenzuela AR, Perucho NS. [The effectiveness of a 0.1% polyhexanide gel]. Rev Enferm. 2008 Apr;31(4):7-12. Spanish.

  PMID: 18564781 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.

  PMID: 34109103 BACKGROUND

• Andriessen AE, Eberlein T. Assessment of a wound cleansing solution in the treatment of problem wounds. Wounds. 2008 Jun;20(6):171-5.

  PMID: 25942522 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.

  PMID: 30040537 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.

  PMID: 36401595 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.

  PMID: 36197316 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.

  PMID: 36002762 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.

  PMID: 31061644 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.

  PMID: 26137277 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.

  PMID: 25745624 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Surgical Wound Infection; Surgical Wound

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Ovunc Bardakcioglu, MD

  Kirk Kerkorian School of Medicine at UNLV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail W Cheng, MD

CONTACT

9166954159; abigail.cheng@unlv.edu

Lance Horner, MD

CONTACT

7755445456; lance.horner@unlv.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking. This is a non-blinded randomized controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Colorectal Surgery

Model Details: Participants will be randomly assigned to one of the two treatment groups.

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 13, 2024
• Study Start: March 14, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)