Trials Sponsors Conditions Drugs Pricing

Conditions

Ostomy - Ileostomy or Colostomy Stoma Complications Stoma Malfunction Stoma Site Dermatitis Stoma Site Infection Peristomal Wound Infection Peristomal Skin Complication Stomal Bleeding Stoma Site Incisional Hernia Retraction of Colostomy Retraction of Ileostomy

Keywords

Surgical stomasIleostomyColostomyEnterostomyOstomySutureAbsorbable suturesStoma complicationsColorectal SurgeryPolyglactin 910Chromic GutErythemaPruritisEnterostomy prolapseEnterostomy ischemiaEnterostomy retractionPeristomal infectionSkin irritationMucocutaneous separation

Outcome Measures

Primary Outcomes (1)

Early Local Stoma Complications
Our primary endpoint will be the number of local complications within 45 days. We will assess mucocutaneous separation, skin, irritation, ischemia, prolapse, retraction, bleeding, and peristomal infection. The evaluations will be conducted by study members while inpatient, at clinic follow up, and/or by assessment of patient photographs sent through HIPPA-encrypted email. Evaluations will be completed, and photos will be taken immediately post operatively, during admission, and at two subsequent follow up appointments after discharge from index operation.
From enrollment up to 90 days post operatively.

Secondary Outcomes (3)

Post-operative Pain After Enterostomy Creation
From enrollment up to 90 days post operatively.

Study Arms (2)

Chromic gut right, polyglactin 910 left

OTHER

The right hemi-circumference of the enterostomy is matured with chromic gut suture and the left hemi-circumference with polyglactin 910 suture.

Device: Chromic Gut SutureDevice: Polyglactin 910 Suture

Chromic gut left, polyglactin 910 right

OTHER

The left hemi-circumference of the enterostomy is matured with chromic gut suture and the right hemi-circumference with polyglactin 910 suture.

Device: Chromic Gut SutureDevice: Polyglactin 910 Suture

Interventions

Chromic Gut SutureDevice

Absorbable chromic gut suture used to mature one hemi-circumference of the enterostomy. The side is determined by randomized arm assignment.

Also known as: Chromic catgut, Chromic surgical gut

Chromic gut left, polyglactin 910 rightChromic gut right, polyglactin 910 left

Polyglactin 910 SutureDevice

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients are required to be 18 years or older
Patients undergoing creation of enterostomy

Sponsors & Collaborators

University of Southern California
Otherlead

Study Sites (1)

Keck Hospital of University of Southern California

Los Angeles, California, 90033, United States

USC Colorectal Surgery Research FellowCONTACT323-865-3690 apg_033@usc.edu

MeSH Terms

Conditions

ErythemaPruritus

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Masking Details: Participants are not informed which suture is placed on which side. Outcome assessments are performed by an investigator who is not present at the operation and who is blinded to the side-assignment. The operating surgeon cannot be masked.
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Chief of Colon and Rectal Surgery and Costello Clinical Professor at Keck Medicine of USC

Study Record Dates

First Submitted

October 7, 2026

First Posted

October 28, 2026

Study Start

Suture Choice for Ostomy Creation

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Chromic gut right, polyglactin 910 left

Chromic gut left, polyglactin 910 right

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Chromic gut right, polyglactin 910 left

Chromic gut left, polyglactin 910 right

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations