An interventional study of Linear Wound Management Protocol in Diverting Ileostomy and Rectal Cancer, sponsored by Dnipro Regional Clinical Oncology Dispensary. Completed at 1 site in Ukraine. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Dnipro Regional Clinical Oncology Dispensary · Not applicable, Interventional, and Treatment
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.
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.
1,804 studies on the registry are indexed under Rectal Neoplasms; 520 are open to participants now.
This study's enrollment of 23 is below the median of 66 across 1,330 interventional studies indexed under Rectal Neoplasms.
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Exclusion Criteria:
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.
Procedure: Linear Wound Management Protocol
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.
Procedure: Linear Wound Management Protocol
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.
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.
Time frame: From surgery through postoperative day 30; assessed on postoperative day 2, at discharge, postoperative day 7, and postoperative day 30
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Data and supporting information will be available beginning after publication of the primary study results and will remain available for 5 years after publication.
Access criteria: Requests will be considered by the corresponding author and study investigators. Access may be granted to qualified researchers for scientifically justified purposes, subject to applicable ethical, institutional, and privacy requirements. Requests should include a brief research proposal and the intended use of the data. Deidentified data and supporting documents may be provided electronically after approval of the request and, where appropriate, completion of a data use agreement.
Ran from Jun 2026 to primary completion in Aug 2026, 2 months.
Of 299 non-industry interventional studies with no phase under Rectal Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 78. This study's 2 months is below that.
Counting every sponsor, half of 309 studies reached it within 51 months; a quarter within 23 and three quarters within 75.
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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 ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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