Diverting IleostomyNCT07892404
Purse-String Versus Linear Closure After Ileostomy Reversal
A study testing Linear Wound Management Protocol and Purse-String Wound Management Protocol in people with Diverting Ileostomy and Rectal Cancer, run by Dnipro Regional Clinical Oncology Dispensary at 1 site in Ukraine.
Trial summary
This randomized study compared two wound closure and wound care protocols after reversal of a diverting ileostomy in adults previously treated surgically for rectal cancer. Participants were assigned to either purse-string skin closure with central drainage access or linear skin closure with marginal drainage access. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverting Ileostomy, Rectal Cancer
- What is being tested?
- Linear Wound Management Protocol and Purse-String Wound Management Protocol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUkraine
- Study dates
- 10 Jun 2026to 10 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults aged 18 years or older.
- History of low anterior resection for rectal cancer with creation of a diverting ileostomy.
- Planned ileostomy reversal 35-40 days after the primary operation.
- Colorectal anastomotic integrity and patency confirmed before reversal by contrast enema and rectosigmoidoscopy.
- Written informed consent to participate.
Who cannot join
- Planned ileostomy reversal outside the 35-40-day interval.
- Clinical or instrumental evidence of colorectal anastomotic leakage.
- Active infection.
- Severe decompensated comorbidity.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Purse-String Versus Linear Closure With Drainage Access After Diverting Ileostomy Reversal in an Exploratory Randomized Comparison of Two Wound Management Protocols
This randomized study compared two wound closure and wound care protocols after reversal of a diverting ileostomy in adults previously treated surgically for rectal cancer. Participants were assigned to either purse-string skin closure with central drainage access or linear skin closure with marginal drainage access. Both protocols included temporary passive drainage and standardized postoperative wound irrigation. The study evaluated postoperative wound healing and wound-related outcomes during 30 days of follow-up. The hypothesis was that the purse-string protocol would be associated with fewer clinically important wound complications than the linear closure protocol.
Read the detailed description
This was a prospective, single-center, parallel-group randomized exploratory surgical study conducted in adults undergoing reversal of a diverting ileostomy created during low anterior resection for rectal cancer. The protocol permitted recruitment of up to 30 participants during a predefined recruitment period.
Participants were randomized in an intended 1:1 ratio using identical opaque sealed envelopes prepared before recruitment. Allocation was revealed after enrollment and induction of general anesthesia, immediately before the first skin incision.
In the purse-string protocol, the skin was approximated with a circular subcuticular purse-string suture while retaining a small central opening for drainage and postoperative wound irrigation. In the linear protocol, the skin was closed with interrupted sutures while retaining a small marginal opening for the same purpose. Both groups received the same perioperative antibiotic regimen, temporary passive drainage removed on postoperative day 1, and standardized postoperative wound irrigation.
Participants were followed for 30 days after surgery. Wound status, postoperative pain, length of hospital stay, superficial wound closure time, and early wound/scar status were assessed according to the study protocol. The study was exploratory and no formal efficacy sample size calculation was performed.
- Conditions
- Diverting Ileostomy, Rectal Cancer
- Being tested
- Linear Wound Management Protocol, Purse-String Wound Management Protocol
- Keywords
- Ileostomy Reversal, Stoma Closure, Purse-String Closure, Linear Skin Closure, Surgical Wound Healing, Wound Management, Southampton Wound Assessment Scale
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear Wound Management ProtocolProcedure or surgery
After diverting ileostomy reversal, the skin was closed with interrupted sutures, leaving a marginal opening no greater than 5 mm for drainage and postoperative irrigation. A temporary passive rubber drain was placed through the opening and removed on postoperative day 1. The wound cavity was irrigated once daily with 20 mL of 0.05% aqueous chlorhexidine during hospitalization and for three days after discharge, followed by dry wound care.
Purse-String Wound Management ProtocolProcedure or surgery
After diverting ileostomy reversal, subcutaneous tissue was approximated using absorbable sutures. The skin was closed with a circular subcuticular purse-string suture, leaving a central opening no greater than 5 mm for drainage and irrigation. A temporary passive rubber drain was placed through the opening and removed on postoperative day 1. The wound cavity was irrigated daily with 20 mL of 0.05% aqueous chlorhexidine during hospitalization and for three days after discharge, followed by dry wound care.
| Study group | Role | What they receive |
|---|---|---|
| Purse-String Closure With Drainage Access | Experimental | Participants underwent purse-string skin closure after diverting ileostomy reversal. A circular subcuticular purse-string suture was used, leaving a central opening of no more than 5 mm for drainage and postoperative wound irrigation. A temporary passive rubber drain was placed through the opening and removed on postoperative day 1. Receives: Procedure: Purse-String Wound Management Protocol |
| Linear Closure With Drainage Access | Active comparator | Participants underwent linear skin closure after diverting ileostomy reversal. The skin was closed with interrupted sutures, leaving a marginal opening of no more than 5 mm for drainage and postoperative wound irrigation. A temporary passive rubber drain was placed through the opening and removed on postoperative day 1. Receives: Procedure: Linear Wound Management Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With a Southampton Wound Grade III-V Event
Number of participants with at least one Southampton Wound Assessment Scale grade III-V event at scheduled postoperative assessments. Wounds were assessed on postoperative day 2, at hospital discharge, postoperative day 7, and postoperative day 30. The highest Southampton grade recorded across these scheduled assessments was used to determine whether the participant met the primary outcome.
Measured: From surgery through postoperative day 30; assessed on postoperative day 2, at discharge, postoperative day 7, and postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start10 Jun 2026
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diverting IleostomyStudies 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
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dnipro Regional Clinical Oncology Dispensary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dmytro Y Savenkov, MD, PhD, Principal investigator, Dnipropetrovsk regional oncology dispensary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892404
- Sponsor's protocol ID
- ILEO-PSLC-2026
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant-level data underlying the results reported in the primary publication will be available, including baseline characteristics, randomized group assignment, the primary Southampton wound outcome, and available secondary outcome data. Direct personal identifiers and clinical photographs will not be shared as part of the IPD dataset.
Publications
O'Leary DP, Carter M, Wijewardene D, Burton M, Waldron D, Condon E, Coffey JC, Peirce C. The effect of purse-string approximation versus linear approximation of ileostomy reversal wounds on morbidity rates and patient satisfaction: the 'STOMA' trial. Tech Coloproctol. 2017 Nov;21(11):863-868. doi: 10.1007/s10151-017-1713-x. Epub 2017 Nov 17.
PubMed 29149428Lee JT, Marquez TT, Clerc D, Gie O, Demartines N, Madoff RD, Rothenberger DA, Christoforidis D. Pursestring closure of the stoma site leads to fewer wound infections: results from a multicenter randomized controlled trial. Dis Colon Rectum. 2014 Nov;57(11):1282-9. doi: 10.1097/DCR.0000000000000209.
PubMed 25285695Dusch N, Goranova D, Herrle F, Niedergethmann M, Kienle P. Randomized controlled trial: comparison of two surgical techniques for closing the wound following ileostomy closure: purse string vs direct suture. Colorectal Dis. 2013 Aug;15(8):1033-40. doi: 10.1111/codi.12211.
PubMed 23634717
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Purse-String Versus Linear Closure With Drainage Access After Diverting Ileostomy Reversal in an Exploratory Randomized Comparison of Two Wound Management Protocols
- ClinicalTrials.gov ID
- NCT07892404
- Acronym / sponsor ID
- ILEO-PSLC-2026
- Conditions
- Diverting Ileostomy, Rectal Cancer
- Keywords
- Ileostomy Reversal, Stoma Closure, Purse-String Closure, Linear Skin Closure, Surgical Wound Healing, Wound Management, Southampton Wound Assessment Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Dnipro Regional Clinical Oncology DispensaryUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 23 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.
This randomized study compared two wound closure and wound care protocols after reversal of a diverting ileostomy in adults previously treated surgically for rectal cancer. Participants were assigned to either purse-string skin closure with central drainage access or linear skin closure with marginal drainage access. Both protocols included temporary passive drainage and standardized postoperative wound irrigation. The study evaluated postoperative wound healing and wound-related outcomes during 30 days of follow-up. The hypothesis was that the purse-string protocol would be associated with fewer clinically important wound complications than the linear closure protocol.
Detailed description
This was a prospective, single-center, parallel-group randomized exploratory surgical study conducted in adults undergoing reversal of a diverting ileostomy created during low anterior resection for rectal cancer. The protocol permitted recruitment of up to 30 participants during a predefined recruitment period.
Participants were randomized in an intended 1:1 ratio using identical opaque sealed envelopes prepared before recruitment. Allocation was revealed after enrollment and induction of general anesthesia, immediately before the first skin incision.
In the purse-string protocol, the skin was approximated with a circular subcuticular purse-string suture while retaining a small central opening for drainage and postoperative wound irrigation. In the linear protocol, the skin was closed with interrupted sutures while retaining a small marginal opening for the same purpose. Both groups received the same perioperative antibiotic regimen, temporary passive drainage removed on postoperative day 1, and standardized postoperative wound irrigation.
Participants were followed for 30 days after surgery. Wound status, postoperative pain, length of hospital stay, superficial wound closure time, and early wound/scar status were assessed according to the study protocol. The study was exploratory and no formal efficacy sample size calculation was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purse-String Closure With Drainage Access | Experimental | Procedure: Purse-String Wound Management ProtocolParticipants underwent purse-string skin closure after diverting ileostomy reversal. A circular subcuticular purse-string suture was used, leaving a central opening of no more than 5 mm for drainage and postoperative wound irrigation. A temporary passive rubber drain was placed through the opening and removed on postoperative day 1. |
| Linear Closure With Drainage Access | Active comparator | Procedure: Linear Wound Management ProtocolParticipants underwent linear skin closure after diverting ileostomy reversal. The skin was closed with interrupted sutures, leaving a marginal opening of no more than 5 mm for drainage and postoperative wound irrigation. A temporary passive rubber drain was placed through the opening and removed on postoperative day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- History of low anterior resection for rectal cancer with creation of a diverting ileostomy.
- Planned ileostomy reversal 35-40 days after the primary operation.
- Colorectal anastomotic integrity and patency confirmed before reversal by contrast enema and rectosigmoidoscopy.
- Written informed consent to participate.
Key exclusion criteria (5 listed)
- Planned ileostomy reversal outside the 35-40-day interval.
- Clinical or instrumental evidence of colorectal anastomotic leakage.
- Active infection.
- Severe decompensated comorbidity.
- Refusal to participate.
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 |
|---|---|---|
| Linear Wound Management ProtocolAfter diverting ileostomy reversal, the skin was closed with interrupted sutures, leaving a marginal opening no greater than 5 mm for drainage and postoperative irrigation. A temporary passive rubber drain was placed through the opening and removed on postoperative day 1. The wound cavity was irrigated once daily with 20 mL of 0.05% aqueous chlorhexidine during hospitalization and for three days after discharge, followed by dry wound care. | Procedure or surgery | Linear Closure With Drainage Access |
| Purse-String Wound Management ProtocolAfter diverting ileostomy reversal, subcutaneous tissue was approximated using absorbable sutures. The skin was closed with a circular subcuticular purse-string suture, leaving a central opening no greater than 5 mm for drainage and irrigation. A temporary passive rubber drain was placed through the opening and removed on postoperative day 1. The wound cavity was irrigated daily with 20 mL of 0.05% aqueous chlorhexidine during hospitalization and for three days after discharge, followed by dry wound care. | Procedure or surgery | Purse-String Closure With Drainage Access |
Primary outcome
Participants With a Southampton Wound Grade III-V Event
Time frame: From surgery through postoperative day 30; assessed on postoperative day 2, at discharge, postoperative day 7, and postoperative day 30
Number of participants with at least one Southampton Wound Assessment Scale grade III-V event at scheduled postoperative assessments. Wounds were assessed on postoperative day 2, at hospital discharge, postoperative day 7, and postoperative day 30. The highest Southampton grade recorded across these scheduled assessments was used to determine whether the participant met the primary outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 29149428O'Leary DP, Carter M, Wijewardene D, Burton M, Waldron D, Condon E, Coffey JC, Peirce C. The effect of purse-string approximation versus linear approximation of ileostomy reversal wounds on morbidity rates and patient satisfaction: the 'STOMA' trial. Tech Coloproctol. 2017 Nov;21(11):863-868. doi: 10.1007/s10151-017-1713-x. Epub 2017 Nov 17.
- Results publication: PubMed 25285695Lee JT, Marquez TT, Clerc D, Gie O, Demartines N, Madoff RD, Rothenberger DA, Christoforidis D. Pursestring closure of the stoma site leads to fewer wound infections: results from a multicenter randomized controlled trial. Dis Colon Rectum. 2014 Nov;57(11):1282-9. doi: 10.1097/DCR.0000000000000209.
- Results publication: PubMed 23634717Dusch N, Goranova D, Herrle F, Niedergethmann M, Kienle P. Randomized controlled trial: comparison of two surgical techniques for closing the wound following ileostomy closure: purse string vs direct suture. Colorectal Dis. 2013 Aug;15(8):1033-40. doi: 10.1111/codi.12211.
- Individual participant dataSharing planned: Yes. Deidentified individual participant-level data underlying the results reported in the primary publication will be available, including baseline characteristics, randomized group assignment, the primary Southampton wound outcome, and available secondary outcome data. Direct personal identifiers and clinical photographs will not be shared as part of the IPD dataset.
Related trials for Diverting Ileostomy
Not yet recruiting
Diverting Ileostomy and Transverse Colostomy Comparative Study
Ileostomy, Colostomy
Recruiting
Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision
Rectal Cancer
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. This study is not recruiting at the moment.
Dmytro Y Savenkov, MD, PhD principal investigator
Dnipropetrovsk regional oncology dispensary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linear Wound Management Protocol and Purse-String Wound Management Protocol in people with Diverting Ileostomy and Rectal Cancer, run by Dnipro Regional Clinical Oncology Dispensary at 1 site in Ukraine.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 27 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 Ukraine. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With a Southampton Wound Grade III-V Event (time frame: From surgery through postoperative day 30; assessed on postoperative day 2, at discharge, postoperative day 7, and postoperative day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07892404, which also lists 3 linked publications.
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 27 Oct 2026.