Colorectal Disorders, Surgical Site Infection, Wound Surgical
Conditions
Keywords
Ostomy, Surgical Site Infection, Primary Closure, Secondary Closure
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.
Interventions
DRUGPrimary 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.
PROCEDUREPursestring 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.
Sponsors
University of Nevada, Las Vegas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking. This is a non-blinded randomized controlled trial
Intervention model description
Participants will be randomly assigned to one of the two treatment groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Wound healing | Until complete wound closure (estimated up to 4-6 weeks post-operation). | Time to wound-healing |
Countries
United States
Contacts
Primary ContactAbigail W Cheng, MD
Backup ContactLance Horner, MD
Outcome results
None listed