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

Trial Summary

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 data supports the effectiveness of the treatment for ostomy wounds?

Research shows that using a purse-string closure technique for ostomy wounds can reduce the risk of infection compared to traditional linear closure methods. This technique allows for better drainage and healing, which can lead to improved outcomes for patients. ^{1 2 3 4 5}

Is the treatment of wound irrigation and purse-string closure generally safe for humans?

The use of 0.1% polyhexanide-betaine solution, known as Prontosan, has been studied in chronic wounds and showed benefits with few patients needing extra antibiotics, suggesting it is generally safe. The purse-string suture technique is recommended for stoma closure to help with healing and drainage, indicating it is a safe method for wound closure. ^{2 6 7 8 9}

How is the treatment of wound irrigation with betaine/polyhexanide and purse-string closure unique for ostomy wounds?

This treatment is unique because it combines a special wound irrigation solution with betaine and polyhexanide, which helps clean and disinfect the wound, with a purse-string closure technique that reduces the risk of infection and improves the appearance of the scar compared to traditional methods. ^{1 7 9 10 11}

What is the purpose of this trial?

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.

Research Team

Ovunc Bardakcioglu, MD

Principal Investigator

Kirk Kerkorian School of Medicine at UNLV

Eligibility Criteria

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 unable to give consent by myself.

I am under 18 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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 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 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]

References

1. Pakistan 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of negative pressure wound therapy for the wound of ileostomy closure: a multicenter, phase II randomized controlled trial. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Purse-string approximation is superior to primary skin closure following stoma reversal: a systematic review and meta-analysis. [2022]

4. England 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Primary closure of stoma site wounds after ostomy takedown. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

0.1% Polyhexanide-Betaine Solution as an Adjuvant in a Case-Series of Chronic Wounds. [2018]

7. England 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. [2015]

8. England pubmed.ncbi.nlm.nih.gov

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

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Conventional Linear versus Purse-string Skin Closure after Loop Ileostomy Reversal: Comparison of Wound Infection Rates and Operative Outcomes. [2021]

10. United States 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. [2020]

11. India pubmed.ncbi.nlm.nih.gov

Evidence-based adoption of purse-string skin closure for stoma wounds. [2022]