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Evaluating the effectiveness of the existing 'linear suture + wound drain placement' and 'purse-string suture + negative pressure wound therapy' through a prospective comparative study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linear skin closure with wound drain | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Check at postoperative 30th day and report through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeehye Lee, MD | Contact | +82-31-787-6555 | jlee0531@snubh.org |
| Name | Affiliation | Role |
|---|---|---|
| Duck-Woo Kim, MD PhD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
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| Purse-string skin closure with negative pressure wound therapy | 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. |
|
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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