The Efficacy of Purse-string Skin Closure With Negative Pressure Wound Therapy (NPWT) After Ileostomy Reversal

NCT ID: NCT04986111

Last Updated: 2021-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-25

Study Completion Date

2022-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluating the effectiveness of the existing 'linear suture + wound drain placement' and 'purse-string suture + negative pressure wound therapy' through a prospective comparative study

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Site Infection Wound Heal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Linear skin closure with wound drain

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.

Group Type EXPERIMENTAL

Linear skin closure with wound drain

Intervention Type PROCEDURE

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 therapy

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.

Group Type ACTIVE_COMPARATOR

Purse-string skin closure with negative pressure wound therapy

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Linear skin closure with wound drain

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.

Intervention Type PROCEDURE

Purse-string skin closure with negative pressure wound therapy

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients experiencing ileostomy repair at multicenter

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Duck-Woo Kim, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jeehye Lee, MD

Role: CONTACT

+82-31-787-6555

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Duck-Woo Kim, MD PhD

Role: primary

+82-31-787-7101

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B-2007/627-003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

VAC NPWT KCI Dressing Study
NCT01366105 WITHDRAWN NA