Surgical Site Infection, Wound Heal
Conditions
Brief 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
Interventions
PROCEDURELinear 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.
PROCEDUREPurse-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.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unsuccessful wound recovery rate | 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 |
Countries
South Korea
Contacts
Primary ContactJeehye Lee, MD
Outcome results
None listed