Ostomy - Ileostomy or ColostomyNCT07900711
Suture Choice for Ostomy Creation
A study testing Chromic Gut Suture and Polyglactin 910 Suture in people with Ostomy - Ileostomy or Colostomy and Stoma Complications, run by University of Southern California at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostomy - Ileostomy or Colostomy, Stoma Complications, Stoma Site Dermatitis
- What is being tested?
- Chromic Gut Suture and Polyglactin 910 Suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are required to be 18 years or older
- Patients undergoing creation of enterostomy
- Patients able and willing to provide informed consent
Who cannot join
- Patients with known suture material allergy
- Patients with preexisting active infection at the operative site
- Patients with known coagulopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Keck Hospital of University of Southern California
Los Angeles, California, 90033
USC Colorectal Surgery Research Fellow, 323-865-3690, apg_033@usc.edu
About this study
Official title: Chromic Gut Versus Polyglactin 910 Suture for Enterostomy Maturation
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:
- Does the choice of suture material affect the rate of early local stoma complications?
- Does the choice of suture material affect post operative pain at the stoma site?
Read more
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:
- Undergo creation of an ostomy as part of their planned operation, with one half of the stoma matured using chromic gut suture and the other half using polyglactin 910 suture, with the side assigned at random
- Attend two follow up visits after discharge from the hospital for their index operation
Read the detailed description
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.
- Conditions
- Ostomy - Ileostomy or Colostomy, Stoma Complications, Stoma Site Dermatitis, Stoma Site Infection, Peristomal Wound Infection, Peristomal Skin Complication
- Being tested
- Chromic Gut Suture, Polyglactin 910 Suture
- Keywords
- Surgical stomas, Ileostomy, Colostomy, Enterostomy, Ostomy, Suture, Absorbable sutures, Stoma complications, Colorectal Surgery, Polyglactin 910, Chromic Gut, Erythema, Pruritis, Enterostomy prolapse, Enterostomy ischemia, Enterostomy retraction, Peristomal infection, Skin irritation, Mucocutaneous separation
- Medical subject headings
- Erythema, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chromic Gut SutureDevice
Also called Chromic catgut, Chromic surgical gut
Absorbable chromic gut suture used to mature one hemi-circumference of the enterostomy. The side is determined by randomized arm assignment.
Polyglactin 910 SutureDevice
Also called Vicryl
Absorbable polyglactin 910 suture used to mature the hemi-circumference opposite the chromic gut suture. The side is determined by randomized arm assignment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Chromic Gut Suture; Device: 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. Receives: Device: Chromic Gut Suture; Device: Polyglactin 910 Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment up to 90 days post operatively.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Immediately following stoma creation (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ostomy - Ileostomy or ColostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-stoma design. Each participant receives both sutures, one on each hemi-circumference of the enterostomy. Participants are randomized to the side-assignment of the two sutures. Each participant serves as his or her own control.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Won Lee, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900711
- Sponsor's protocol ID
- APP-25-05207
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chromic Gut Versus Polyglactin 910 Suture for Enterostomy Maturation
- ClinicalTrials.gov ID
- NCT07900711
- Acronym / sponsor ID
- APP-25-05207
- Conditions
- Ostomy - Ileostomy or Colostomy, Stoma Complications, Stoma Site Dermatitis, Stoma Site Infection, Peristomal Wound Infection, Peristomal Skin Complication
- Keywords
- Surgical stomas, Ileostomy, Colostomy, Enterostomy, Ostomy, Suture, Absorbable sutures, Stoma complications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the choice of suture material affect the rate of early local stoma complications?
- Does the choice of suture material affect post operative pain at the stoma site?
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:
- Undergo creation of an ostomy as part of their planned operation, with one half of the stoma matured using chromic gut suture and the other half using polyglactin 910 suture, with the side assigned at random
- Attend two follow up visits after discharge from the hospital for their index operation
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-stoma design. Each participant receives both sutures, one on each hemi-circumference of the enterostomy. Participants are randomized to the side-assignment of the two sutures. Each participant serves as his or her own control.
| Arm | Type | Receives |
|---|---|---|
| Chromic gut right, polyglactin 910 left | Other | Device: Chromic Gut Suture, Device: Polyglactin 910 SutureThe right hemi-circumference of the enterostomy is matured with chromic gut suture and the left hemi-circumference with polyglactin 910 suture. |
| Chromic gut left, polyglactin 910 right | Other | Device: Chromic Gut Suture, Device: Polyglactin 910 SutureThe left hemi-circumference of the enterostomy is matured with chromic gut suture and the right hemi-circumference with polyglactin 910 suture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients are required to be 18 years or older
- Patients undergoing creation of enterostomy
- Patients able and willing to provide informed consent
Key exclusion criteria (3 listed)
- Patients with known suture material allergy
- Patients with preexisting active infection at the operative site
- Patients with known coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chromic Gut SutureAlso: Chromic catgut, Chromic surgical gutAbsorbable chromic gut suture used to mature one hemi-circumference of the enterostomy. The side is determined by randomized arm assignment. | Device | Chromic gut left, polyglactin 910 right, Chromic gut right, polyglactin 910 left |
| Polyglactin 910 SutureAlso: VicrylAbsorbable polyglactin 910 suture used to mature the hemi-circumference opposite the chromic gut suture. The side is determined by randomized arm assignment. | Device | Chromic gut left, polyglactin 910 right, Chromic gut right, polyglactin 910 left |
Primary outcome
Early Local Stoma Complications
Time frame: From enrollment up to 90 days post operatively.
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.
3 secondary outcomes
Post-operative Pain After Enterostomy Creation
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)
Time frame: From enrollment up to 90 days post operatively.
Surgeon-Reported Suture Handling Score (5-Point Likert Scale Questionnaire)
Time frame: Immediately following stoma creation (Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keck Hospital of University of Southern California
Los Angeles, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chromic Gut Suture and Polyglactin 910 Suture in people with Ostomy - Ileostomy or Colostomy and Stoma Complications, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Local Stoma Complications (time frame: From enrollment up to 90 days post operatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.