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

Nevada System of Higher Education (NSHE)

Status and phase: Enrolling; Phase 4

Conditions: Wound Surgical; Surgical Site Infection; Colorectal Disorders

Treatments: Drug: Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation; Procedure: Pursestring Closure

Study type: Interventional

Funder types: Other

Identifiers

NCT06309368

003875

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

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

Secondary Closure with Pursestring

Active Comparator group

Description:

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

Treatment:

Procedure: Pursestring Closure