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This is a prospective randomized controlled trial conducted at Ain Shams University Maternity Hospital to compare subcutaneous drain versus wound irrigation with normal saline for the prevention of surgical site infection following cesarean section in obese patients. Eligible women were randomly assigned to either subcutaneous drain placement or intraoperative wound irrigation, or subcutaneous skin closure only. The primary outcome was the incidence of surgical site infection, with additional assessment of postoperative wound complications and recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous Drain group | Experimental | A Drain is put subcutaneously to drain any excess fluid |
|
| Wound irrigation group | Active Comparator | The wound is irrigated with Normal saline before wound closure intraoperatively. |
|
| Only Subcutaneous closure | No Intervention | Subcutaneous closure with vicryl with no additional intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous Drain | Procedure | Subcutaneous Drain is put before wound closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of surgical site infection | Assessment of surgical site infection according to standard clinical criteria following cesarean section in the study groups. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Wound complications | Dehiscence of wound, cosmetic evaluation, need for surgical intervention. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Female, obese, Pregnant patients
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| Name | Affiliation | Role |
|---|---|---|
| Mahmoud M. Ghaleb | Department of Obstetrics and Gynecology, faculty of Medicine, Ain Shams University | Principal Investigator |
| Waleed H. Ahmed | Department of Obstetrics and Gynecology, faculty of Medicine, Ain Shams University | Principal Investigator |
| Mohammad A. Alzeiny | Department of Obstetrics and Gynecology, faculty of Medicine, Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University, Maternity Hospital | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Gül DK. The role of saline irrigation of subcutaneous tissue in preventing surgical site complications during cesarean section: A prospective randomized controlled trial. J Surg Med. 2021;5(1):8-11. | ||
| 31942268 | Background | Anfinan N, Sait KH. Appropriate Management of Subcutaneous Tissue of Midline Abdominal Incisions. Cureus. 2020 Jan 3;12(1):e6549. doi: 10.7759/cureus.6549. | |
| 33578671 |
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| Normal Saline | Procedure | wound irrigation with Normal Saline before wound closure |
|
|
| Background |
| Slabuszewska-Jozwiak A, Szymanski JK, Jozwiak L, Sarecka-Hujar B. A Systematic Review and Meta-Analysis of Wound Complications after a Caesarean Section in Obese Women. J Clin Med. 2021 Feb 10;10(4):675. doi: 10.3390/jcm10040675. |
| Background | ProCon.org. Global obesity levels (2020). Available online at: https://obesity.procon.org/global-obesity-levels/ (accessed June 28, 2020) |
| Background | Centers for Disease Control and Prevention. National Healthcare Safety Network (NHSN) Patient Safety Component Manual. 2021 https:// www. cdc. gov/ nhsn/ pdfs/ validation/2021/pcsmanual_2021-508.pdf. Accessed August 10, 2022 |
| 34537018 | Background | Gomaa K, Abdelraheim AR, El Gelany S, Khalifa EM, Yousef AM, Hassan H. Incidence, risk factors and management of post cesarean section surgical site infection (SSI) in a tertiary hospital in Egypt: a five year retrospective study. BMC Pregnancy Childbirth. 2021 Sep 18;21(1):634. doi: 10.1186/s12884-021-04054-3. |
| 35670438 | Background | Wahdan M, Hakim S, El Gaafary M, Sos D, Wassif G, Hussein W, Mokhtar A, Hussein A, El Awady M, Rady M, Anwar W. Rising trends in Caesarean section in 6 Egyptian governorates. East Mediterr Health J. 2022 May 29;28(5):336-344. doi: 10.26719/emhj.22.012. |
| 37216058 | Background | Angolile CM, Max BL, Mushemba J, Mashauri HL. Global increased cesarean section rates and public health implications: A call to action. Health Sci Rep. 2023 May 18;6(5):e1274. doi: 10.1002/hsr2.1274. eCollection 2023 May. |
| 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 |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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