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

PHASE4RecruitingINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

March 14, 2024

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2029

Conditions
Surgical Site InfectionWound SurgicalColorectal Disorders
Interventions
DRUG

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.

PROCEDURE

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.

Trial Locations (1)

89102

RECRUITING

University Medical Center, Las Vegas

All Listed Sponsors
lead

University of Nevada, Las Vegas

OTHER