Clinical trial NCT06309368: Ostomy Primary Closure With 0.1% Betaine/Polyhexanide Wound Irrigation Compared to Pursestring Closure
Official title: To Close or Not to Close: Surgical Site Infection Rates in Ostomy Primary Closure With 0.1% Betaine/Polyhexanide Wound Irrigation Compared to Conventional Ostomy Closure by Secondary Intention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Surgical Site Infection
Wound Surgical
Colorectal Disorders
Keywords: Ostomy
Surgical Site Infection
Primary Closure
Secondary Closure
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of the two treatment groups.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical Site Infection Rates
timeFrame: Evaluate surgical site for any signs of infection up to 30 days post-operatively.
Secondary outcomes:
measure: Acceptability of wound or scar healing by patient
timeFrame: Up to one year post-operatively.
measure: Amount of percepted wound care needed by patient
timeFrame: Up to 4 weeks after compete wound closure.
measure: Acceptability of wound and scar healing by patient
timeFrame: At 4 weeks post complete wound closure and at one year post-operatively.
measure: Wound healing
timeFrame: Until complete wound closure (estimated up to 4-6 weeks post-operation).
measure: Acceptability of wound and scar healing by patient
timeFrame: Up to one year post-operatively
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University Medical Center
state: Nevada
Study officials:
affiliation: Kirk Kerkorian School of Medicine at UNLV
name: Ovunc Bardakcioglu, MD
role: PRINCIPAL_INVESTIGATOR
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