Surgical Site Infection: The Clinical and Economic Impact.
Megan C Turner, John Migaly
https://pubmed.ncbi.nlm.nih.gov/31061644/Actively Recruiting
Led by University of Nevada, Las Vegas · Updated on 2025-06-02
84
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating two different methods of closing ostomy wounds in patients ready for ostomy closure, focusing on surgical site infection rates, patient quality of life, and time to wound healing. The study compares primary ostomy closure after washing the wound with a 0.1% betaine and 0.1% polyhexanide antimicrobial solution Prontosan to the Pursestring closure method, where the wound is partially closed and allowed to heal from the inside out. This trial aims to find better treatment options for wound closure in colorectal surgery patients by comparing these approaches. Participants will be randomly assigned to one of two groups. One group will have their ostomy wound fully closed after irrigation with the Prontosan solution, involving a detailed suturing procedure. The other group will have their wound partially closed using the Pursestring technique, which leaves the wound open in the center to heal naturally. Both surgical procedures involve wound irrigation and specific closure techniques. The study will monitor outcomes for up to one year after surgery. During the study, participants will be monitored for signs of surgical site infection up to 30 days after surgery. Researchers will also assess wound healing time, patient perceptions of scar and wound healing, and the amount of wound care needed up to one year post-operation. Data will be collected on wound healing progress until complete closure, estimated around 4 to 6 weeks. The study includes various assessments to evaluate patient quality of life and wound outcomes over time.
CONDITIONS
Ostomy Primary Closure With 0.1% Betaine/Polyhexanide Wound Irrigation Compared to Pursestring Closure
A
Abigail W Cheng, MD
L
Lance Horner, MD
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
University of Nevada, Las Vegas
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Primary Closure + PHMB/Betadine Irrigation | Pursestring Closure Technique |
|---|---|---|
| What is it? | The surgical closure site is irrigated with a solution containing 0.1% betaine and 0.1% polyhexanide, then closed primarily with sutures and skin glue after ileostomy reversal. | A circular incision is made, followed by partial closure of the skin in a pursestring fashion with the center left open and packed, after standard anastomosis and fascial closure. |
| Role in the study | Investigational intervention tested for reduction in surgical site infections after ileostomy reversal. | Active comparator arm, using pursestring closure, a common current method for wound management after ileostomy reversal. |
| Primary use | To attempt reduction of post-operative surgical site infections through combined antiseptic wound irrigation and complete skin closure. | To lower the risk of surgical site infection by allowing wound exudate to drain through a partially open wound, a technique supported by published comparative studies. |
| How is it performed? | After an elliptical transverse incision, the wound is irrigated with 350cc of PHMB/betaine solution, then suctioned dry, and the tissue and skin are closed with sutures and skin glue. | A circular incision is closed partially using a pursestring suture; the center of the wound is left open and packed to allow drainage. Saline irrigation is used before closure. |
| What is known from clinical studies? | No clinical outcome results are yet available for this arm in this population. Previous studies of PHMB/betaine solution suggest reduced infection rates in other types of wound care, but not specifically for ileostomy closure. | Pursestring closure has been repeatedly shown in comparative studies to lower surgical site infection rates after stoma reversal compared to conventional or primary closure techniques. |
| Important limitations | The effectiveness of PHMB/betaine irrigation with primary closure specifically for stoma reversal has not yet been established in randomized clinical trials. Safety data for this combination in clean surgical wounds are limited. | While pursestring closure reduces infection rates, it may result in a slower wound healing process and requires ongoing wound care, according to comparative studies. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery and hospital stay
Participants undergo ostomy closure surgery using either 0.1% Betaine/0.1% Polyhexanide wound irrigation with primary closure or the Pursestring closure method, followed by immediate post-operative care.
1 surgical visit (in-person)
Duration - Up to 1 year post-operatively
Participants are monitored for surgical site infection and wound healing, including assessments of wound closure and scar acceptability up to one year after surgery.
Multiple visits including assessment at 4 weeks and up to 1 year after surgery
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Megan C Turner, John Migaly
https://pubmed.ncbi.nlm.nih.gov/31061644/Zimeng Chang, Liang Liu, Canfang She...
https://pubmed.ncbi.nlm.nih.gov/36401595/Sang Il Yoon, Sun Mi Bae, Hwan Namgung...
https://pubmed.ncbi.nlm.nih.gov/25745624/Dawn M Cooper, Chris Bojke, Pinaki Ghosh
https://pubmed.ncbi.nlm.nih.gov/36990897/Anneke E Andriessen, Thomas Eberlein
https://pubmed.ncbi.nlm.nih.gov/25942522/Yuma Wada, Norikatsu Miyoshi, Masayuki Ohue...
https://pubmed.ncbi.nlm.nih.gov/26137277/Ahmed Siddiqi, Zuhdi E Abdo, Bryan D Springer...
https://pubmed.ncbi.nlm.nih.gov/34109103/Yibin Zhu, Jianxun Chen, Shuangming Lin...
https://pubmed.ncbi.nlm.nih.gov/36002762/Munyaradzi G Nyandoro, Yi Th'ng Seow, Joel Stein...
https://pubmed.ncbi.nlm.nih.gov/36197316/Annekatrien L van de Kar, Leonard U M Corion, Mark J C Smeulders...
https://pubmed.ncbi.nlm.nih.gov/16079683/University of Nevada, Las Vegas
Lead Sponsor