An interventional study of Chromic Gut Suture and Polyglactin 910 Suture in Ostomy - Ileostomy or Colostomy, Stoma Complications and Stoma Site Dermatitis, sponsored by University of Southern California. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether chromic gut or polyglactin 910 suture results in fewer stoma complications when used to mature an enterostomy in patients undergoing planned ostomy creation. The main questions it aims to answer are:
Researchers will compare the half of the stoma matured with chromic gut to the half matured with polyglactin 910, within the same participant, to see if one suture leads to fewer complications.
Participants will:
Enterostomy maturation is performed by suturing the full thickness of the bowel edge to the dermis, and the choice of suture material is not standardized. Chromic gut and polyglactin 910 are both absorbable and both in routine use, but they differ in tensile strength retention, absorption profile, and tissue reactivity. These properties may be related to early stomal complications, including mucocutaneous separation, peristomal skin irritation, and surgical site infection, yet comparative data are limited and current practice rests largely on individual surgeon preference.
This is a randomized, non-inferiority study participant- and assessor-blinded trial using a split-stoma design. Eligible participants are those undergoing creation of an enterostomy as part of a planned operation. Randomization is performed at the time of stoma creation in a 1:1 ratio to one of two side-assignments: chromic gut to the right hemi-circumference with polyglactin 910 to the left, or the reverse. All other aspects of the operation, including stoma site selection, aperture size, eversion technique, suture size, and number of sutures placed, follow a standardized approach and do not differ between the two halves.
The rationale for the split-stoma approach is that between-patient variability in stoma outcomes is substantial and driven by factors such as body habitus, nutritional status, bowel wall thickness, urgency of the operation, and underlying disease. Using each participant as an internal control removes this variability from the comparison and permits detection of differences between suture materials with a smaller sample than a conventional parallel-group trial would require.
Each hemi-circumference is assessed independently immediately post operatively, during the patient's admission, and at the first and second outpatient follow up appointment by an investigator who did not participate in the operation and who is blinded to the side-assignment. The primary outcome is early stoma complications assessed separately for each half of the stoma. Secondary outcomes include pain at the stoma site, effect of patient co-morbidities on early stoma complications, and record of surgeon experience using each type of suture. Analysis is performed within participants, comparing paired observations from the two hemi-circumferences using methods appropriate for matched data.
The operating surgeon cannot be blinded, since suture selection is performed intra-operatively. Blinding is maintained for participants and outcome assessors.
131 studies on the registry are indexed under Erythema; 17 are open to participants now.
This study's planned enrollment of 66 is above the median of 50 across 114 interventional studies indexed under Erythema.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 Suture · Device: Polyglactin 910 Suture
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 Suture · Device: Polyglactin 910 Suture
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
Absorbable polyglactin 910 suture used to mature the hemi-circumference opposite the chromic gut suture. The side is determined by randomized arm assignment.
Also known as: Vicryl
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.
Time frame: From enrollment up to 90 days post operatively.
Post-operative Pain After Enterostomy Creation
Assess patient-reported peristomal pain using the Visual Analog Scale (VAS) on each side of the enterostomy. The scale is 0 to 10 with 0 indicating "No Pain" and 10 indicating "Worst Pain." The higher the score, the worse the patient's reported pain.
Time frame: From enrollment up to 90 days post operatively.
Adjusted Odds of Stoma Complications by Patient and Stoma Characteristics (Age, Sex, BMI, ASA Class, Comorbidities, Stoma Type)
Patient factors will be abstracted from the medical record at enrollment: age (years), sex, BMI (kg/m2, calculated from measured height and weight), ASA physical status class (I-V), smoking status (current/former/never), and presence (yes/no) of diabetes, active malignancy, steroid use, history of chemotherapy or radiation, cardiac disease, and renal disease. Stoma type (end colostomy, end ileostomy, loop colostomy, loop ileostomy) will be recorded in the peri-operative period. The outcome is occurrence of any stoma complication as defined in "Outcome 1" with multivariable logistic regression to estimate the adjusted odds ratio for each factor, with suture type (Chromic vs. Vicryl) as a covariate.
Time frame: From enrollment up to 90 days post operatively.
Surgeon-Reported Suture Handling Score (5-Point Likert Scale Questionnaire)
Surgeon experience for each suture type will be measured with a study-specific, 5-point Likert questionnaire. The operating surgeon will complete one for Vicryl suture and one for Chromic suture immediately after stoma maturation. Items included in the questionnaire will be rated from 1 (strongly disagree) to 5 (strongly agree). Items scores will be summed into a total score per suture type with higher scores indicating a better surgeon experience. Mean total scores will be compared between the two sutures. The questionnaire also includes a free-text field for observed intra-operative differences; these will be summarized descriptively and are not part of the score.
Time frame: Immediately following stoma creation (Day 0)
Plan to share: Yes — De-identified individual participant data underlying the published results, including all primary and secondary outcome measures, will be made available along with a data dictionary.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 6 months after publication of the primary results and ending 3 years thereafter.
Access criteria: Requests should be directed to the principal investigator at sangwl@med.usc.edu. Proposals will be reviewed by the study team, and data will be released following execution of a data use agreement and approval by the USC IRB.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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