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NCT Number: NCT06309368

Ostomy Primary Closure With 0.1% Betaine/Polyhexanide Wound Irrigation Compared to Pursestring Closure

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.

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Key information

Conditions

Surgical Site Infection Colorectal Disorders Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Surgical Wound Infection Wound Infection Wound Surgical Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center

Las Vegas, Nevada, 89102, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients 18 years or older with an diverting loop ileostomy reversal indication will be enrolled
  • Signed consent

Exclusion criteria

  • Under 18 years old, unable to provide consent, has a parastomal hernia requiring mesh repair, or has an end ileostomy

Treatment and study plan

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

Drug

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.

Other names: Prontosan

Pursestring Closure

Procedure

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.

Primary outcomes

  1. Surgical Site Infection Rates

    Time frame: Evaluate surgical site for any signs of infection up to 30 days post-operatively.

    Evaluate surgical site infection rates between the two treatment arms

Secondary outcomes

  1. Acceptability of wound or scar healing by patient

    Time frame: Up to one year post-operatively.

    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.

  2. Amount of percepted wound care needed by patient

    Time frame: Up to 4 weeks after compete wound closure.

    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.

  3. Acceptability of wound and scar healing by patient

    Time frame: At 4 weeks post complete wound closure and at one year post-operatively.

    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.

  4. Wound healing

    Time frame: Until complete wound closure (estimated up to 4-6 weeks post-operation).

    Time to wound-healing

  5. Acceptability of wound and scar healing by patient

    Time frame: Up to one year post-operatively

    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.

Interested in participating?

Recruiting

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Sponsors and collaborators

Lead sponsor

University of Nevada, Las Vegas

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Mar 13, 2024
Registry last updated
Jun 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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