Recruiting

Betaine/Polyhexanide vs. Pursestring

Sponsor:

University of Nevada, Las Vegas

Code:

NCT06309368

Conditions

Surgical Site Infection

Wound Surgical

Colorectal Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

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

Pursestring Closure

Study Details

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. 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.

Conditions

Surgical Site Infection

Wound Surgical

Colorectal Disorders

Study ID

NCT06309368

Start date

Mar 14, 2024

Status verified date

May, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Primary Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation

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

active comparator: Secondary Closure with Pursestring

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

Interventions

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

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.

Pursestring Closure

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.

Primary outcome measure

  • Surgical Site Infection Rates [ Time Frame: Evaluate surgical site for any signs of infection up to 30 days post-operatively. ]

Central Contacts and Locations

Central contacts

Abigail W Cheng, MD

9166954159abigail.cheng@unlv.edu

Lance Horner, MD

7755445456lance.horner@unlv.edu

Locations

University Medical Center

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Abigail W Cheng, MD

9166954159abigail.cheng@unlv.edu

Lance Horner, MD

7755445456lance.horner@unlv.edu

Principal Investigator:

Ovunc Bardakcioglu, MD

More Information

Sponsor

University of Nevada, Las Vegas

Last update posted

Jun 2, 2025

Last verified

May, 2025

Keywords

  • Ostomy
  • Surgical Site Infection
  • Primary Closure
  • Secondary Closure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of Nevada, Las Vegas on 2025-06-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.