Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale.
Annekatrien L van de Kar, Leonard U M Corion, Mark J C Smeulders...
https://pubmed.ncbi.nlm.nih.gov/16079683Actively Recruiting
Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
ID06309368
Ostomy Primary Closure with 0.1% Betaine/Polyhexanide Wound Irrigation Compared to Pursestring Closure for Surgical Site Infection Rates
Led by University of Nevada, Las Vegas · Updated on 2025-06-02
84
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Brief Title
Ostomy Primary Closure With 0.1% Betaine/Polyhexanide Wound Irrigation Compared to Pursestring Closure
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older with a diverting loop ileostomy reversal indication
- Signed informed consent
You will not qualify if you...
- Under 18 years old
- Unable to provide consent
- Presence of parastomal hernia requiring mesh repair
- Having an end ileostomy type of stoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
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)
Post-operative Follow-up
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
Trial Site Locations
Total: 1 location
1
University Medical Center
Las Vegas, Nevada, United States, 89102
Actively Recruiting
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Research Team
A
Abigail W Cheng, MD
L
Lance Horner, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Cost-Effectiveness of PHMB & betaine wound bed preparation compared with standard care in venous leg ulcers: A cost-utility analysis in the United Kingdom.
Dawn M Cooper, Chris Bojke, Pinaki Ghosh
https://pubmed.ncbi.nlm.nih.gov/36990897[The effectiveness of a 0.1% polyhexanide gel].
Andrés Roldán Valenzuela, Nuria Serra Perucho
https://pubmed.ncbi.nlm.nih.gov/18564781Pursuit of the ideal antiseptic irrigation solution in the management of periprosthetic joint infections.
Ahmed Siddiqi, Zuhdi E Abdo, Bryan D Springer...
https://pubmed.ncbi.nlm.nih.gov/34109103Assessment of a wound cleansing solution in the treatment of problem wounds.
Anneke E Andriessen, Thomas Eberlein
https://pubmed.ncbi.nlm.nih.gov/25942522Does Wound Irrigation with Clorhexidine Gluconate Reduce the Surgical Site Infection Rate in Closure of Temporary Loop Ileostomy? A Prospective Clinical Study.
Mustafa Goztok, Mustafa Cem Terzi, Tufan Egeli...
https://pubmed.ncbi.nlm.nih.gov/30040537A meta-analysis examined the effect of stoma on surgical site wound infection in colorectal cancer.
Zimeng Chang, Liang Liu, Canfang She...
https://pubmed.ncbi.nlm.nih.gov/36401595Single-centre experience of loop ileostomy closure: a retrospective comparison of conventional-linear closure and purse-string closure on surgical-site-infection rates.
Munyaradzi G Nyandoro, Yi Th'ng Seow, Joel Stein...
https://pubmed.ncbi.nlm.nih.gov/36197316Risk factor for the development of surgical site infection following ileostomy reversal: a single-center report.
Yibin Zhu, Jianxun Chen, Shuangming Lin...
https://pubmed.ncbi.nlm.nih.gov/36002762Surgical Site Infection: The Clinical and Economic Impact.
Megan C Turner, John Migaly
https://pubmed.ncbi.nlm.nih.gov/31061644