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The goal of this clinical trial is to compare the outcomes of High-volume saline irrigation vs Povidone-iodine solution cleaning of the intraoperative incision wound in preventing superficial surgical site infections in patients undergoing emergency laparotomies. The main question it aims to answer are:
Participants will be randomly assigned to two groups receiving either of the two groups:
Group A: 1000ml of IOWI with saline solution prior to incision closure Group B: The incisional wound will be closed conventionally without irrigation.
Researchers will compare groups A( experimental group) and B (control group) to compare the incidence of superficial surgical site infections after intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Intra-operative wound irrigation of 0.9% solution saline solution |
|
| Group B | Active Comparator | No intra-operative wound lavage done |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9% saline solution | Procedure | During emergency laparotomy, after the primary surgical procedure. the sheath will be sutured and the incision site will then be irrigated with three rounds of 1 liter of 0.9% saline solution, which will be completely aspirated before the closure of the incisional wound in experimental group. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Superficial Surgical site infections | Development of Superficial Surgical Site Infection as determined by the CDC guidelines. | Upto 4 weeks post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Number of in-hospital days (from time of admission to time of discharge) | Upto 4 weeks post-operatively |
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Inclusion Criteria:
• Patients undergoing emergency laparotomy under the care of surgical-6 unit of Dr. Ruth K. M. Pfau Civil Hospital Karachi
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omer Bin Khalid, Assist Prof. | Contact | +92 321 2040064 | dromerkhalid@gmail.com | |
| Afeera Ahmed, Undergraduate | Contact | +923352547330 | afeeranws@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Omer Bin Khalid, Assist Prof. | Dr. Ruth F. M. Pfau Civil Hospital Karachi | Principal Investigator |
| Imrana Zulfikar, Professor | Dr. Ruth F. M. Pfau Civil Hospital Karachi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Ruth K. M. Pfau Civil Hospital Karachi | Recruiting | Karachi | Sindh | 74400 | Pakistan |
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|
| Povidone-iodine Swab | Procedure | No intra-operative wound lavage done, and wound would be cleaned with povidone doused swab. |
|
|
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D000072836 | Surgical Wound |
| D014946 | Wound Infection |
| D049291 | Seroma |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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