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

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
University of Nevada, Las Vegas
Study ID
NCT06309368
Phase
PHASE4
Status
Recruiting
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Conditions

  • Colorectal Disorders
  • Surgical Site Infection
  • Wound Surgical

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Mar 14, 2024
Status verified
May 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Primary Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation
    The ostomy wound will be irrigated with 0.1% Betaine/0.1% Polyhexanide wound irrigation, then closed completely with sutures.
  • Active Comparator: Secondary Closure with Pursestring
    The ostomy wound will be partially closed using the Pursestring method.

Primary Outcome Measure

Surgical Site Infection Rates [ Time Frame: Evaluate surgical site for any signs of infection up to 30 days post-operatively. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Medical CenterLas VegasNevada89102
Abigail W Cheng, MD
[email protected]
9166954159
Lance Horner, MD
[email protected]
7755445456
Ovunc Bardakcioglu, MD (PRINCIPAL_INVESTIGATOR)
Lance Horner, MD (PRINCIPAL_INVESTIGATOR)
Abigail W Cheng, MD (SUB_INVESTIGATOR)
Henry Krasner, BS (SUB_INVESTIGATOR)
Kavita Batra, PhD (SUB_INVESTIGATOR)

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By research site
University Medical Center· Las Vegas, NV

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