Clinical trial

To Close or Not to Close: Surgical Site Infection Rates in Ostomy Primary Closure With 0.1% Betaine/0.1% Polyhexanide Wound Irrigation Compared to Conventional Ostomy Closure by Secondary Intention

Name

003875

Description

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.

Trial arms

Trial start

2024-03-14

Estimated PCD

2024-12-01

Trial end

2025-12-01

Status

Recruiting

Phase

Early phase I

Treatment

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

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.

Arms:

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

Other names:

Prontosan

Pursestring Closure

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.

Arms:

Secondary Closure with Pursestring

Size

Primary endpoint

Surgical Site Infection Rates

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

Eligibility criteria

Inclusion Criteria: * All patients 18 years or older with an ostomy reversal indication will be enrolled Exclusion Criteria: * Patients under 18 years old and patients unable to provide consent

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to one of the two treatment groups.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking. This is a non-blinded randomized controlled trial'}}, 'enrollmentInfo': {'count': 84, 'type': 'ESTIMATED'}}

Updated at

2024-03-25

1 organization

1 product

3 indications

Organization

University of Nevada, Las Vegas

Product

Primary Ostomy Closure

Indication

SSIs

Indication

Surgical Wound

Indication

Colorectal Disorders