NCT Number: NCT06309368
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Las Vegas, Nevada, 89102, United States
Location status: Recruiting
Abigail W Cheng, MD
CONTACT
Abigail W Cheng, MD
SUB_INVESTIGATOR
Henry Krasner, BS
SUB_INVESTIGATOR
Kavita Batra, PhD
SUB_INVESTIGATOR
Lance Horner, MD
CONTACT
Lance Horner, MD
PRINCIPAL_INVESTIGATOR
Ovunc Bardakcioglu, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Prontosan
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.
Time frame: Evaluate surgical site for any signs of infection up to 30 days post-operatively.
Evaluate surgical site infection rates between the two treatment arms
Time frame: 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.
Time frame: 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.
Time frame: At 4 weeks post complete wound closure and at one year post-operatively.
Evaluation of patient's perception of their ostomy wound and scar appearance using the Patient and Observer Scar Assessment Scale - Observer scale. The minimum value is 1 and maximum value is 10, with the higher score meaning a worse outcome.
Time frame: Until complete wound closure (estimated up to 4-6 weeks post-operation).
Time to wound-healing
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Abigail W Cheng, MD
CONTACT
Lance Horner, MD
CONTACT
University of Nevada, Las Vegas
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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