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

Phase 4

Recruiting

• Conditions: Wound Surgical; Colorectal Disorders; Surgical Site Infection
• Interventions: Procedure: Pursestring Closure; Drug: Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation

• Registration Number: NCT06309368
• Lead Sponsor: University of Nevada, Las Vegas

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.

Detailed Description

Surgical site infection (SSI) is a common yet potentially serious and devastating complication in colorectal surgery, with rates of up to 25%, many of which are preventable. In stoma closure, SSI rates have been reported as up to 40% with conventional closure techniques. SSI adds more burden to the patient, requiring additional therapy, such as antibiotics, wound drainage, and even wound debridement. This results in longer hospital length of stay and can ultimately negatively impact a patient's quality of life. Additionally, allowing a wound to heal by secondary intention has been demonstrated to have worse cosmetic outcomes compared to primary closure, which may also impact quality of life (QoL) for patients. The investigators aim to investigate the outcomes (including SSI rates and QoL) of patients who underwent two different standards of care in ostomy closure: primary skin closure after usage of Prontosan, a 0.1% betaine and 0.1 % polyhexamethylene biguanide antimicrobial solution, and secondary intention healing after Pursestring closure. Comparing these two closure methods, may yield further insight into better treatment options for wound closures in colorectal surgery patients.

Patients will be recruited in the UNLV Colorectal Clinic at their appointments, and surgeries will be done at University Medical Center. Patient recruitment and informed consent will be performed by the co-investigators. The sample size is calculated for a non-inferiority trial with a 2.5% level of significance, 90% power of test and an expected SSI rate of 3% for the purse-string closure group and 25.9% for the primary wound closure without 0.1% betaine/0.1% polyhexanide). The sample size needed is 42 patients in each study arm with an assumed 20% attrition rate. Data will be analyzed by the statistician.

Study Timeline

• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-13
• Study Start: 2024-03-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-06-02
• Primary Completion: 2028-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Secondary Closure with Pursestring	Pursestring Closure	The ostomy wound will be partially closed using the Pursestring method.
Primary Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation	Primary Ostomy 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.

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection Rates	Evaluate surgical site for any signs of infection up to 30 days post-operatively.	Evaluate surgical site infection rates between the two treatment arms

Secondary Outcome Measures

Name	Time	Method
Acceptability of wound or scar healing by patient	Up to one year post-operatively.	Evaluation of patient's perception of their ostomy wound or scar appearance using the Visual Analog Scale. The minimum value is 0, maximum value is 10, with the higher score meaning a worse outcome.
Amount of percepted wound care needed by patient	Up to 4 weeks after compete wound closure.	Evaluation of patient's perception of the amount of wound care needed during the healing of their ostomy wound using the Visual Analog Scale. The minimum value is "no wound care needed" and maximum value is "maximum amount of wound care needed", with "maximum amount of wound care needed" being the worst outcome.
Acceptability of wound and scar healing by patient	Up to one year post-operatively	Evaluation of patient's satisfaction of their ostomy wound and scar appearance using the Likert Scale. The minimum value is "very dissatisfied" and maximum value is "very satisfied", with "very satisfied being the best outcome.
Wound healing	Until complete wound closure (estimated up to 4-6 weeks post-operation).	Time to wound-healing

Trial Locations

Locations (1)

University Medical Center; 🇺🇸 Las Vegas, Nevada, United States