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| Name | Class |
|---|---|
| Thammasat Hospital | UNKNOWN |
| Chonburi hospital | OTHER_GOV |
| Vachira hospital | UNKNOWN |
| Pathumtani Hospital |
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Research hypothesis:
Does delayed primary wound closure after appendectomy in adults with complicated appendicitis reduce postoperative superficial surgical site infection compare to primary wound closure.
Study design:
This study is a multicenter randomized controlled trial of delay versus primary wound closure in complicated appendicitis.
Setting:
Thammasat Hospital, Ramathibodi Hospital, Chonburi Hospital, Chonpratarn Hospital, Vachira Hospital, and Pathumthani Hospital
Participants:
Adult patients age 18 years or older and non-pregnant in women who have been diagnosed as gangrenous or ruptured appendicitis.
Outcome:
Superficial surgical site infection
Period of study:
August 2012 - August 2014
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary wound closure | Experimental | A wound will be sutured immediately after the operative procedure uisng non-absorbable monofilament suture or stapler at intervals of one centimeter apart and 0.5 cm back from a wound edge. |
|
| Delayed primary wound closure | Active Comparator | A wound will be left open with saline-soaked gauze packing after the operative procedure and will be sutured around day 3 to 7 after operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary wound closure | Procedure | A wound will be sutured immediately after the operative procedure uisng non-absorbable monofilament suture or stapler at intervals of one centimeter apart and 0.5 cm back from a wound edge. |
| Measure | Description | Time Frame |
|---|---|---|
| Superficial surgical site infection (SSI) | Superficial SSI, which will be diagnosed using the Center for Disease Control (CDC) criteria as follows:
| within 1 month after operation |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | • Postoperative pain will be assessed using visual analog scale (VAS, ranged from 0-10) at day 1 and 3 | within 3 days after operation |
| Quality of life | Quality of life will be assessed using the Thai EQ5D questionnaires before an operation, days 3 and 1 month after operation |
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Inclusion criteria
Adult patients age 18 years or older
Have been diagnosed as gangrenous or ruptured appendicitis base on clinical criteria with the following conditions
a.Gangrenous appendicitis i.Erythematous or swelling of appendix and ii.Appearance of necrotic wall (dark, grayish color) b.Ruptured appendicitis i. Erythematous or swelling of appendix and ii.Appearance of hole in an appendix or iii.Rupture of appendix during a procedure c.Appearance of frank pus
Non-immunocompromised hosts which include
Non-pregnant women
Willing to participate and provide written informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Boonying Siribumrungwong, MD | Ramathibodi Hospital | Principal Investigator |
| Ammarin Thakkinstian, PhD | Ramathibodi Hospital | Study Chair |
| Patarawan Woratanarat | Ramathibodi Hospital | Study Chair |
| Borwornsom Leerapan | Ramathibodi Hospital | Study Chair |
| Jittunut Hawanon | Thammasat Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vachira hospital | Dusit | Bangkok | 10300 | Thailand | ||
| Department of Surgery, Ramathibodi Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29946346 | Derived | Noorit P, Siribumrungwong B, Thakkinstian A. Clinical prediction score for superficial surgical site infection after appendectomy in adults with complicated appendicitis. World J Emerg Surg. 2018 Jun 18;13:23. doi: 10.1186/s13017-018-0186-1. eCollection 2018. |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D007239 | Infections |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| UNKNOWN |
| Lampang Hospital | OTHER |
| Surin Hospital | UNKNOWN |
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| 1 month after operation |
| Cost of treatment | Both direct and indirect costs of treatment will be recorded | 1 month after operation |
| Rachatevi |
| Bangkok |
| 10400 |
| Thailand |
| Chonburi hospital | Meaung | Changwat Chon Buri | 20000 | Thailand |
| Surin hospital | Meung | Changwat Surin | Thailand |
| Pathumtani hospital | Meung | Pathumtani | 12110 | Thailand |
| Thammasat hospital | Rangsit City Municipality | Patumtani | 12120 | Thailand |
| Lampang hospital | Meung | Thailand |