Surgical Site InfectionPhase 4NCT06309368
Ostomy Primary Closure With 0.1% Betaine/Polyhexanide Wound Irrigation Compared to Pursestring Closure
A Phase 4 study testing Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation and Pursestring Closure in people with Surgical Site Infection and Wound Surgical, run by University of Nevada, Las Vegas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection, Wound Surgical, Colorectal Disorders
- What is being tested?
- Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation and Pursestring Closure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2024to Dec 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients 18 years or older with an diverting loop ileostomy reversal indication will be enrolled
- Signed consent
Who cannot join
- Under 18 years old, unable to provide consent, has a parastomal hernia requiring mesh repair, or has an end ileostomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Medical Center
Las Vegas, Nevada, 89102
Abigail W Cheng, MD, 9166954159, abigail.cheng@unlv.edu
Lance Horner, MD, 7755445456, lance.horner@unlv.edu
About this study
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
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:
- Surgical site infection rates
- Patient quality of life
- 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.
Read the 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.
- Being tested
- Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation, Pursestring Closure
- Keywords
- Ostomy, Surgical Site Infection, Primary Closure, Secondary Closure
- Medical subject headings
- Surgical Wound Infection, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound IrrigationDrug
Also called Prontosan
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.
Pursestring ClosureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation | Active comparator | The ostomy wound will be irrigated with 0.1% Betaine/0.1% Polyhexanide wound irrigation, then closed completely with sutures. Receives: Drug: Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation |
| Secondary Closure with Pursestring | Active comparator | The ostomy wound will be partially closed using the Pursestring method. Receives: Procedure: Pursestring Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection Rates
Evaluate surgical site infection rates between the two treatment arms
Measured: Evaluate surgical site for any signs of infection up to 30 days post-operatively.
Secondary outcomes (5)
Acceptability of wound or scar healing by patient
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.
Measured: Up to one year post-operatively.
Amount of percepted wound care needed by patient
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.
Measured: Up to 4 weeks after compete wound closure.
Acceptability of wound and scar healing by patient
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.
Measured: At 4 weeks post complete wound closure and at one year post-operatively.
Wound healing
Time to wound-healing
Measured: Until complete wound closure (estimated up to 4-6 weeks post-operation).
Acceptability of wound and scar healing by patient
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.
Measured: Up to one year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start14 Mar 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of the two treatment groups.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ovunc Bardakcioglu, University of Nevada, Las Vegas
- Investigators
- Ovunc Bardakcioglu, MD, Principal investigator, Kirk Kerkorian School of Medicine at UNLV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309368
- Sponsor's protocol ID
- 003875
- Status last verified
- May 2025
- First submitted
- 22 Feb 2024
- Last updated
- 2 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
PubMed 16079683Cooper DM, Bojke C, Ghosh P. Cost-Effectiveness of PHMB & betaine wound bed preparation compared with standard care in venous leg ulcers: A cost-utility analysis in the United Kingdom. J Tissue Viability. 2023 May;32(2):262-269. doi: 10.1016/j.jtv.2023.03.001. Epub 2023 Mar 16.
PubMed 36990897Valenzuela AR, Perucho NS. [The effectiveness of a 0.1% polyhexanide gel]. Rev Enferm. 2008 Apr;31(4):7-12. Spanish.
PubMed 18564781Siddiqi A, Abdo ZE, Springer BD, Chen AF. Pursuit of the ideal antiseptic irrigation solution in the management of periprosthetic joint infections. J Bone Jt Infect. 2021 May 26;6(6):189-198. doi: 10.5194/jbji-6-189-2021. eCollection 2021.
PubMed 34109103Andriessen AE, Eberlein T. Assessment of a wound cleansing solution in the treatment of problem wounds. Wounds. 2008 Jun;20(6):171-5.
PubMed 25942522Goztok M, Terzi MC, Egeli T, Arslan NC, Canda AE. Does Wound Irrigation with Clorhexidine Gluconate Reduce the Surgical Site Infection Rate in Closure of Temporary Loop Ileostomy? A Prospective Clinical Study. Surg Infect (Larchmt). 2018 Aug/Sep;19(6):634-639. doi: 10.1089/sur.2018.061. Epub 2018 Jul 24.
PubMed 30040537Chang Z, Liu L, She C, Ren W, Chen H, Zhou C. A meta-analysis examined the effect of stoma on surgical site wound infection in colorectal cancer. Int Wound J. 2023 May;20(5):1578-1583. doi: 10.1111/iwj.14013. Epub 2022 Nov 19.
PubMed 36401595Nyandoro MG, Seow YT, Stein J, Theophilus M. Single-centre experience of loop ileostomy closure: a retrospective comparison of conventional-linear closure and purse-string closure on surgical-site-infection rates. ANZ J Surg. 2023 Mar;93(3):629-635. doi: 10.1111/ans.18083. Epub 2022 Oct 5.
PubMed 36197316Zhu Y, Chen J, Lin S, Xu D. Risk factor for the development of surgical site infection following ileostomy reversal: a single-center report. Updates Surg. 2022 Oct;74(5):1675-1682. doi: 10.1007/s13304-022-01335-0. Epub 2022 Aug 24.
PubMed 36002762Turner MC, Migaly J. Surgical Site Infection: The Clinical and Economic Impact. Clin Colon Rectal Surg. 2019 May;32(3):157-165. doi: 10.1055/s-0038-1677002. Epub 2019 Apr 2.
PubMed 31061644Wada Y, Miyoshi N, Ohue M, Noura S, Fujino S, Sugimura K, Akita H, Motoori M, Gotoh K, Takahashi H, Kobayashi S, Ohmori T, Fujiwara Y, Yano M. Comparison of surgical techniques for stoma closure: A retrospective study of purse-string skin closure versus conventional skin closure following ileostomy and colostomy reversal. Mol Clin Oncol. 2015 May;3(3):619-622. doi: 10.3892/mco.2015.505. Epub 2015 Feb 6.
PubMed 26137277Yoon SI, Bae SM, Namgung H, Park DG. Clinical trial on the incidence of wound infection and patient satisfaction after stoma closure: comparison of two skin closure techniques. Ann Coloproctol. 2015 Feb;31(1):29-33. doi: 10.3393/ac.2015.31.1.29. Epub 2015 Feb 28.
PubMed 25745624