Surgical Site Infection (SSI)NCT07517718
Subcutaneous Drain Versus Wound Irrigation by Normal Saline for Prevention of Surgical Site Infection Following Caesarean Section in Obese Patients.
A study testing Subcutaneous Drain and Normal Saline in people with Surgical Site Infection (SSI) and Cesarean Section Wound, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Surgical Site Infection (SSI), Cesarean Section Wound
- What is being tested?
- Subcutaneous Drain and Normal Saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jan 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Obese Pregnant women who attend for cesarean section.
- Aged 18 to 50 years old.
- BMI ≥ 30 kg/m2.
Who cannot join
- Preoperative uncontrolled infection.
- Prolonged premature rupture of membranes.
- Severe surgical blood loss >1000ml.
- Uncontrolled Pregestational Diabetes mellitus type 1 and type2.
- Uncontrolled Gestational Diabetes mellitus.
- Uncontrolled Hypertension with pregnancy.
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- Preeclampsia and Eclampsia, Pregnancy-induced hypertension (PIH).
- Chronic medical disorders including chronic kidney disease, chronic hepatitis, chronic autoimmune disease and chronic heart disease.
- Anemia with pregnancy.
- Patient with Immunodeficiency disorders and patients on immunosuppressive drugs.
- Patient with recent history of drug abuse.
- Smoker.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subcutaneous Drain Versus Wound Irrigation by Normal Saline for Prevention of Surgical Site Infection Following Caesarean Section in Obese Patients: A Prospective Randomized Controlled Trial.
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.
- Being tested
- Subcutaneous Drain, Normal Saline
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous DrainProcedure or surgery
Also called Drain insertion subcutaneously
Subcutaneous Drain is put before wound closure
Normal SalineProcedure or surgery
Also called Normal saline (NS) 0.9%
wound irrigation with Normal Saline before wound closure
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous Drain group | Experimental | A Drain is put subcutaneously to drain any excess fluid Receives: Procedure: Subcutaneous Drain |
| Wound irrigation group | Active comparator | The wound is irrigated with Normal saline before wound closure intraoperatively. Receives: Procedure: Normal Saline |
| Only Subcutaneous closure | No intervention | Subcutaneous closure with vicryl with no additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical site infection
Assessment of surgical site infection according to standard clinical criteria following cesarean section in the study groups.
Measured: 10 days
Secondary outcomes (1)
Wound complications
Dehiscence of wound, cosmetic evaluation, need for surgical intervention.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start9 Jan 2025
- Primary completion15 Jul 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Surgical Site Infection (SSI)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud M. Ghaleb, Principal investigator, Department of Obstetrics and Gynecology, faculty of Medicine, Ain Shams UniversityWaleed H. Ahmed, Principal investigator, Department of Obstetrics and Gynecology, faculty of Medicine, Ain Shams UniversityMohammad A. Alzeiny, Principal investigator, Department of Obstetrics and Gynecology, faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517718
- Sponsor's protocol ID
- 2024-790
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 31942268Slabuszewska-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.
PubMed 33578671ProCon.org. Global obesity levels (2020). Available online at: https://obesity.procon.org/global-obesity-levels/ (accessed June 28, 2020)
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
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.
PubMed 34537018Wahdan 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.
PubMed 35670438Angolile 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.
PubMed 37216058
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Drain Versus Wound Irrigation by Normal Saline for Prevention of Surgical Site Infection Following Caesarean Section in Obese Patients: A Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07517718
- Acronym / sponsor ID
- 2024-790
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous Drain group | Experimental | Procedure: Subcutaneous DrainA Drain is put subcutaneously to drain any excess fluid |
| Wound irrigation group | Active comparator | Procedure: Normal SalineThe wound is irrigated with Normal saline before wound closure intraoperatively. |
| Only Subcutaneous closure | No intervention | –Subcutaneous closure with vicryl with no additional intervention. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Obese Pregnant women who attend for cesarean section.
- Aged 18 to 50 years old.
- BMI ≥ 30 kg/m2.
Key exclusion criteria (12 listed)
- Preoperative uncontrolled infection.
- Prolonged premature rupture of membranes.
- Severe surgical blood loss >1000ml.
- Uncontrolled Pregestational Diabetes mellitus type 1 and type2.
- Uncontrolled Gestational Diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous DrainAlso: Drain insertion subcutaneouslySubcutaneous Drain is put before wound closure | Procedure or surgery | Subcutaneous Drain group |
| Normal SalineAlso: Normal saline (NS) 0.9%wound irrigation with Normal Saline before wound closure | Procedure or surgery | Wound irrigation group |
Primary outcome
Incidence of surgical site infection
Time frame: 10 days
Assessment of surgical site infection according to standard clinical criteria following cesarean section in the study groups.
1 secondary outcome
Wound complications
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- BackgroundGül 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.
- Background: PubMed 31942268Anfinan N, Sait KH. Appropriate Management of Subcutaneous Tissue of Midline Abdominal Incisions. Cureus. 2020 Jan 3;12(1):e6549. doi: 10.7759/cureus.6549.
- Background: PubMed 33578671Slabuszewska-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.
- BackgroundProCon.org. Global obesity levels (2020). Available online at: https://obesity.procon.org/global-obesity-levels/ (accessed June 28, 2020)
- BackgroundCenters 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
- Background: PubMed 34537018Gomaa 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.
- Background: PubMed 35670438Wahdan 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.
- Background: PubMed 37216058Angolile 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud M. Ghaleb principal investigator
Department of Obstetrics and Gynecology, faculty of Medicine, Ain Shams University
Waleed H. Ahmed principal investigator
Department of Obstetrics and Gynecology, faculty of Medicine, Ain Shams University
Mohammad A. Alzeiny principal investigator
Department of Obstetrics and Gynecology, faculty of Medicine, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous Drain and Normal Saline in people with Surgical Site Infection (SSI) and Cesarean Section Wound, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of surgical site infection (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07517718, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.