Wound Irrigation vs Pursestring Closure for Ostomy Wounds

Overseen By Abigail W Cheng, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Nevada, Las Vegas

Disqualifiers: Under 18, Unable to consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 32

Duration: 1 day (surgery)

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods for closing ostomy wounds after surgery. One method involves washing the wound with Prontosan (0.1% Betaine/0.1% Polyhexanide wound irrigation) and then fully closing it with stitches. The other method, known as the Pursestring technique, leaves the wound partially open to heal from the inside out. Researchers aim to determine which method results in fewer infections, better healing times, and improved quality of life for patients. Individuals who have undergone ileostomy surgery and are ready for reversal may be suitable candidates for this trial. As a Phase 4 trial, this research seeks to understand how these FDA-approved methods benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for these treatments?

Research has shown that a 0.1% betaine–0.1% polyhexanide solution for cleaning wounds appears promising. It effectively breaks down biofilms, which are protective layers of bacteria, and serves as a good disinfectant. Although detailed safety information from these studies is not widely available, its use in advanced clinical research suggests it is likely safe.

Studies have found the Pursestring closure method to be a safe option, offering benefits such as fewer wound infections and improved cosmetic results. This method significantly reduces the risk of infections at the surgical site, a common concern with stoma reversal.

Both treatments are in the later stages of clinical testing, indicating they have already undergone safety checks in earlier stages. This suggests they are generally well-tolerated by patients. However, individual experiences can vary, so it is important to consider personal health conditions and discuss them with a healthcare professional. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatment methods for ostomy wounds because they offer innovative approaches to wound closure. The primary closure technique uses a unique combination of 0.1% Betaine and 0.1% Polyhexanide for wound irrigation, aiming to reduce infection and promote healing by leveraging the antimicrobial properties of these agents. This is different from traditional methods that might not incorporate such targeted antimicrobial irrigation. On the other hand, the pursestring closure method partially closes the wound, which can potentially reduce tension on the wound and improve healing outcomes compared to complete closure techniques. These methods could lead to better healing and fewer complications, making them promising options for patients undergoing ostomy reversal surgeries.

What evidence suggests that this trial's treatments could be effective for ostomy wound closure?

Research shows that using a solution with 0.1% betaine and 0.1% polyhexanide to clean wounds before closing an ostomy might help reduce infections at the surgical site. Early results from case studies suggest this method could lower the risk of infection. In this trial, some participants will receive this primary closure method. Other participants will receive the pursestring closure technique, which allows the wound to heal from the inside out by leaving it partially open. Studies have found that this technique leads to fewer infections and better-looking scars compared to traditional methods. Both techniques aim to improve healing and patient satisfaction, with the pursestring closure showing particular benefits in reducing complications and improving scar appearance. Each method has its advantages, and the trial compares them to determine which is more effective for closing ostomy wounds. ^{1 2 3 4 6}

Who Is on the Research Team?

Ovunc Bardakcioglu, MD

Principal Investigator

Kirk Kerkorian School of Medicine at UNLV

Are You a Good Fit for This Trial?

This trial is for patients with ostomies ready to be closed. It's not specified who can't join, but typically, participants would need to be in good health otherwise and not have conditions that could affect wound healing or increase infection risk.

Inclusion Criteria

I am 18 or older and have been advised to undergo ostomy reversal.

Exclusion Criteria

I am under 18 years old.

I am unable to give consent by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo ostomy wound closure using either primary closure with 0.1% Betaine/0.1% Polyhexanide wound irrigation or secondary closure with the Pursestring method

1 day (surgery)

1 visit (in-person)

Follow-up

Participants are monitored for surgical site infection rates, wound healing, and patient quality of life

4 weeks

Up to 30 days post-operatively

What Are the Treatments Tested in This Trial?

Interventions

• Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation
• Pursestring Closure

Trial Overview The study compares two methods of closing ostomy wounds: one uses a wash called Prontosan before complete closure, while the other uses a Pursestring method leaving the wound partially open. The focus is on infection rates, patient quality of life, and speed of healing.

How Is the Trial Designed?

Group I: Primary Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation Active Control 1 Intervention

The ostomy wound will be irrigated with 0.1% Betaine/0.1% Polyhexanide wound irrigation, then closed completely with sutures.

Group II: Secondary Closure with Pursestring Active Control 1 Intervention

The ostomy wound will be partially closed using the Pursestring method.

Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation is already approved in United States, European Union for the following indications:

Approved in United States as Prontosan for:

• Chronic non-healing wounds
• Surgical wound irrigation
• Ostomy wound closure

Approved in European Union as Prontosan for:

• Chronic non-healing wounds
• Surgical wound irrigation
• Ostomy wound closure

Who Is Running the Clinical Trial?

University of Nevada, Las Vegas

Lead Sponsor

Trials

81

Recruited

14,700+

Published Research Related to This Trial

In a study of 84 patients undergoing ileostomy closure, the purse-string suture (PSS) technique resulted in a significantly lower rate of surgical site infections (SSI) at 0% compared to 24% in the direct suture (DS) group (P = 0.0004).

Both PSS and DS techniques showed similar cosmetic outcomes, suggesting that PSS should be adopted as the standard method for wound closure after ileostomy reversal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial: comparison of two surgical techniques for closing the wound following ileostomy closure: purse string vs direct suture. Dusch, N., Goranova, D., Herrle, F., et al.[2015]

Purse-string approximation (PSA) significantly reduces the incidence of surgical site infections (SSI) following stoma reversal, with rates of 2.4% for PSA compared to 29.6% for primary linear closure (PLC), indicating an 80% reduction in SSI risk.

Patients who underwent PSA reported higher satisfaction with cosmetic outcomes compared to those who had PLC, with no differences in hospital stay length, suggesting that PSA is both effective and favorable for patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Purse-string approximation is superior to primary skin closure following stoma reversal: a systematic review and meta-analysis. McCartan, DP., Burke, JP., Walsh, SR., et al.[2022]

The purse-string closure (PSC) technique for ileostomy wounds significantly reduces the risk of surgical site infections compared to conventional linear closure (CLC), based on a systematic analysis of three randomized controlled trials involving 206 patients.

Both the duration of the operation and the length of hospital stay were similar between the PSC and CLC techniques, indicating that PSC is a safer option without compromising surgical efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of published randomized controlled trials comparing purse-string vs conventional linear closure of the wound following ileostomy (stoma) closure. Sajid, MS., Bhatti, MI., Miles, WF.[2021]

In a study of 41 patients undergoing stoma reversal, purse-string skin closure (PSSC) resulted in significantly lower rates of surgical site infections and shorter healing times compared to conventional primary closure (PC).

Patients who received PSSC reported higher satisfaction with their wound appearance and experienced less need for additional outpatient care, suggesting that PSSC is a more effective technique for stoma wound closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based adoption of purse-string skin closure for stoma wounds. Behuria, N., Banerjee, JK., Ghosh, SR., et al.[2022]

Using negative pressure wound therapy (NPWT) for one week after stoma closure significantly improved wound reduction rates compared to conventional gauze management, particularly on postoperative days 7 and 10.

However, NPWT did not reduce the overall duration of wound healing and was associated with a 20% incidence of surgical site infections (SSIs) in the NPWT groups, highlighting the need for careful monitoring when using this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of negative pressure wound therapy for the wound of ileostomy closure: a multicenter, phase II randomized controlled trial. Kojima, K., Goto, M., Nagashima, Y., et al.[2022]

A study involving 70 patients demonstrated that the antimicrobial solution containing polyhexanide propylbetaine (PP) effectively aids in wound bed preparation, with 73% of patients showing improved wound conditions after 14 days of treatment.

The efficacy of PP in cleaning wounds was time-dependent, with better results observed after 10 to 15 minutes of application, and no adverse effects were reported, indicating it is a safe option for wound cleansing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cleansing versus tailored deep debridement, a fresh approach to wound cleansing: an Italian experience. Ricci, E.[2018]

In a study of 75 patients undergoing ostomy reversal, only 5.3% developed stoma site infections, all of whom had delayed primary closure or packing, suggesting that primary closure does not increase infection rates.

The analysis found no significant association between various factors, such as patient demographics or use of antibiotics, and the risk of developing stoma site wound infections, indicating that primary closure may be a safe option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary closure of stoma site wounds after ostomy takedown. Harold, DM., Johnson, EK., Rizzo, JA., et al.[2012]

The application of 0.1% polyhexanide-betaine gel and solution in treating 70 chronic wounds resulted in a moist healing environment that facilitated wound closure, with venous wounds closing in an average of 29 days and diabetic ulcers taking up to 92 days.

Remarkably, nearly 90% of patients did not require additional antibiotic therapy, suggesting that the antimicrobial properties of polyhexanide-betaine may effectively inhibit bacterial growth and reduce the need for antibiotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

0.1% Polyhexanide-Betaine Solution as an Adjuvant in a Case-Series of Chronic Wounds. Moore, M., Dobson, N., Cetnarowski, W.[2018]

In a study of 48 patients undergoing loop ileostomy reversal, purse-string skin closure resulted in a lower wound infection rate (5.6%) compared to linear closure (16.7%), although this difference was not statistically significant (P = 0.26).

Purse-string skin closure also led to a significantly shorter median hospital stay (7 days) compared to linear closure (11 days), suggesting it may be a more efficient technique for postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conventional Linear versus Purse-string Skin Closure after Loop Ileostomy Reversal: Comparison of Wound Infection Rates and Operative Outcomes. Lee, JR., Kim, YW., Sung, JJ., et al.[2021]

In a randomized control trial involving 80 patients undergoing stoma reversal, the purse-string closure technique significantly reduced the incidence of surgical site infections (SSI) compared to conventional linear closure (3 cases vs. 17 cases, p = 0.003).

Patients who received purse-string closure reported better scar cosmesis and higher satisfaction scores (mean POSAS score of 83.40 vs. 65.30, p = 0.012), indicating that this technique not only minimizes infection risk but also enhances aesthetic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Surgical Site Infection and Scar Cosmesis Between Conventional Linear Skin Closure Versus Purse-string Skin Closure in Stoma Reversal - A Randomized Controlled Trial. Sureshkumar, S., Jubel, K., Ali, MS., et al.[2020]

In a study of 72 patients undergoing ileostomy stoma reversal, purse-string closure resulted in a significantly lower incidence of wound infection (5.4%) compared to linear closure (22.8%).

Patients who received purse-string closure reported higher satisfaction levels at 3 months post-surgery, indicating that this method may be preferable for both safety and cosmetic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of purse-string versus linear skin closure after ileostomy stoma reversal in terms of stoma sites infection and cosmesis. Ali, D., Zubair, M., Kaiser, MA., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06309368

Ostomy Primary Closure With 0.1% Betaine/Polyhexanide ... The investigators aim to investigate the outcomes (including SSI rates and QoL) of patients who underwent two different standards of care in ostomy closure: ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548031/

Primary closure of ileostomy site after irrigation with ... This first preliminary case series suggests that betaine–polyhexanide irrigation may reduce the risk of SSI during primary closure of ileostomy ...

3. ctv.veeva.com ctv.veeva.com/study/ostomy-primary-closure-with-01-betaine-01-polyhexanide-wound-irrigation-compared-to-pursestring

Ostomy Primary Closure With 0.1% Betaine/Polyhexanide ... The goal of this clinical trial is to compare two types of closure in patients with ostomies that are ready for closure.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41140767/

Primary closure of ileostomy site after irrigation with ... This single-institution case series is the first in the literature to evaluate SSI rates with the use of betaine-polyhexanide irrigation and ...

5. academic.oup.com academic.oup.com/jscr/article-pdf/2025/10/rjaf846/64881723/rjaf846.pdf

rjaf846.pdf - Oxford Academic This single-institution case series is the first in the literature to evaluate SSI rates with the use of betaine–polyhexanide irrigation and ...

6. researchgate.net researchgate.net/publication/396832113_Primary_closure_of_ileostomy_site_after_irrigation_with_betaine-polyhexanide_a_case_series

Primary closure of ileostomy site after irrigation with ... This single-institution case series is the first in the literature to evaluate SSI rates with the use of betaine–polyhexanide irrigation and ...