Surgical Site InfectionNCT04986111
The Efficacy of Purse-string Skin Closure With Negative Pressure Wound Therapy (NPWT) After Ileostomy Reversal
A study testing Linear skin closure with wound drain and Purse-string skin closure with negative pressure wound therapy in people with Surgical Site Infection and Wound Heal, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Evaluating the effectiveness of the existing 'linear suture + wound drain placement' and 'purse-string suture + negative pressure wound therapy' through a prospective comparative study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection, Wound Heal
- What is being tested?
- Linear skin closure with wound drain and Purse-string skin closure with negative pressure wound therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jan 2021to 30 Apr 2022
- 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
- Patients experiencing ileostomy repair at multicenter
Who cannot join
- Active bacterial infection needing antibiotics before surgery
- parastomal infection before surgery
- uncontrolled diabetes mellitus
- Emergency repair of stoma (ex. stoma prolapse, high output stoma etc...)
- Inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Duck-Woo Kim, MD PhD, +82-31-787-7101, kdw@snubh.org
About this study
Official title: The Efficacy of Purse-string Skin Closure With Negative Pressure Wound Therapy (NPWT) on Wound Recovery After Ileostomy Reversal: A Prospective Randomized Clinical Trial
Evaluating the effectiveness of the existing 'linear suture + wound drain placement' and 'purse-string suture + negative pressure wound therapy' through a prospective comparative study
- Conditions
- Surgical Site Infection, Wound Heal
- Being tested
- Linear skin closure with wound drain, Purse-string skin closure with negative pressure wound therapy
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear skin closure with wound drainProcedure or surgery
An oval incision is made around the ileostomy and the continuity of the intestinal tract is restored after adhesion division.
Methods of anastomosis include either side-to-side or end-to-end, hand-sewing or stapling.
Linear suture of the rectus abdominis fascia layer by layer. A Jackson-Pratt drainage tube is placed in the subcutaneous tissue and vertical mattress suture is performed with a non-absorbable thread.
Purse-string skin closure with negative pressure wound therapyProcedure or surgery
Recover the intestinal continuity after adhesion division by making a circular incision along the ileostomy Methods of anastomosis include either side-to-side or end-to-end, hand-sewing or stapling.
Linear suture of the rectus abdominis fascia layer by layer. Negative pressure wound therapy is performed after suturing the subcutaneous tissue using absorbable thread.
| Study group | Role | What they receive |
|---|---|---|
| Linear skin closure with wound drain | Experimental | Reduce fluid collection and dead space by inserting drain into the subcutaneous layer using the wound closure method previously used in the experimental center. The linear suture has a relatively quick time to stitch out. Receives: Procedure: Linear skin closure with wound drain |
| Purse-string skin closure with negative pressure wound therapy | Active comparator | Close the wound with a purse-string suture which is better in terms of surgical site infection but known to take a long time for wound healing, and use negative pressure wound therapy to help granulation of tissues and help healing. Receives: Procedure: Purse-string skin closure with negative pressure wound therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unsuccessful wound recovery rate
(patients with unsuccessful wound recovery / all enrolled patients) x 100
**Unsuccessful wound recovery definition: 1) Occurrence of Surgical Site Infection (SSI) or 2) reoperation due to wound complication or 3) delayed healing over 30 days or 4) Out patient department follow up more than 5 times
Measured: Check at postoperative 30th day and report through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start25 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duck-Woo Kim, MD PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986111
- Sponsor's protocol ID
- B-2007/627-003
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Purse-string Skin Closure With Negative Pressure Wound Therapy (NPWT) on Wound Recovery After Ileostomy Reversal: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04986111
- Acronym / sponsor ID
- B-2007/627-003
- Conditions
- Surgical Site Infection, Wound Heal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 2 Aug 2021 (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.
Evaluating the effectiveness of the existing 'linear suture + wound drain placement' and 'purse-string suture + negative pressure wound therapy' through a prospective comparative study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linear skin closure with wound drain | Experimental | Procedure: Linear skin closure with wound drainReduce fluid collection and dead space by inserting drain into the subcutaneous layer using the wound closure method previously used in the experimental center. The linear suture has a relatively quick time to stitch out. |
| Purse-string skin closure with negative pressure wound therapy | Active comparator | Procedure: Purse-string skin closure with negative pressure wound therapyClose the wound with a purse-string suture which is better in terms of surgical site infection but known to take a long time for wound healing, and use negative pressure wound therapy to help granulation of tissues and help healing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients experiencing ileostomy repair at multicenter
Key exclusion criteria (5 listed)
- Active bacterial infection needing antibiotics before surgery
- parastomal infection before surgery
- uncontrolled diabetes mellitus
- Emergency repair of stoma (ex. stoma prolapse, high output stoma etc...)
- Inflammatory bowel disease
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 skin closure with wound drainAn oval incision is made around the ileostomy and the continuity of the intestinal tract is restored after adhesion division. Methods of anastomosis include either side-to-side or end-to-end, hand-sewing or stapling. Linear suture of the rectus abdominis fascia layer by layer. A Jackson-Pratt drainage tube is placed in the subcutaneous tissue and vertical mattress suture is performed with a non-absorbable thread. | Procedure or surgery | Linear skin closure with wound drain |
| Purse-string skin closure with negative pressure wound therapyRecover the intestinal continuity after adhesion division by making a circular incision along the ileostomy Methods of anastomosis include either side-to-side or end-to-end, hand-sewing or stapling. Linear suture of the rectus abdominis fascia layer by layer. Negative pressure wound therapy is performed after suturing the subcutaneous tissue using absorbable thread. | Procedure or surgery | Purse-string skin closure with negative pressure wound therapy |
Primary outcome
Unsuccessful wound recovery rate
Time frame: Check at postoperative 30th day and report through study completion, an average of 1 year
(patients with unsuccessful wound recovery / all enrolled patients) x 100 **Unsuccessful wound recovery definition: 1) Occurrence of Surgical Site Infection (SSI) or 2) reoperation due to wound complication or 3) delayed healing over 30 days or 4) Out patient department follow up more than 5 times
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
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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. This study is not recruiting at the moment.
Duck-Woo Kim, MD PhD principal investigator
Seoul National University Bundang Hospital
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 skin closure with wound drain and Purse-string skin closure with negative pressure wound therapy in people with Surgical Site Infection and Wound Heal, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Aug 2021. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeehye Lee, MD (+82-31-787-6555, jlee0531@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unsuccessful wound recovery rate (time frame: Check at postoperative 30th day and report through study completion, an average of 1 year). 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 2 Aug 2021.