Wound InfectionNCT04177381
Comparative Study Between Subcutaneous Tissue Closure Versus Drain in Obese Women Undergo Elective Cesarean Section
A study testing Cesarean section, subcutanous sutures and subcutanous drain in people with Wound Infection, run by Cairo University at 1 site in Egypt.
Trial summary
Randomised cinical trial in Kasr Alainy Hospital.352 obese women pregnant with gestational age >38 wk ,theire age range from (25-35) years and BMI between (30 -40) undergoing elective cesarean section were randomised into 4 groups and compare the role of subcutaneous tissue closure in post cesarean section wound… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Wound Infection
- What is being tested?
- Cesarean section, subcutanous sutures and subcutanous drain
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Mar 2021to 2 Nov 2022
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- obese women who BMI(30- 40 kg/m2)
- Gestational age (37-41) week calculated by sure dates and confirmed by first trimester US,
- single fetus.
- Elective lower segment cesarean section
Who cannot join
- Any medical disorders affect wound healing as:
- Diabetes mellitus.
- On steroids.
- Immunedeficiency.
- Hypoalbuminemia.
- Skin infections or history of wound infections.
Show all 10Show fewer
- Multifetal pregnancy.
- Obstetric complications eg.placenta previa.
- Anemia.
- Intraoperative complications as intestinal injury or bladder injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Subcutaneous Tissue Closure Versus Drain in Obese Women Undergo Elective Cesarean Section Arandomized Controlled Trial
Randomised cinical trial in Kasr Alainy Hospital.352 obese women pregnant with gestational age >38 wk ,theire age range from (25-35) years and BMI between (30 -40) undergoing elective cesarean section were randomised into 4 groups and compare the role of subcutaneous tissue closure in post cesarean section wound complications.
groups are: 4 groups each group was 86 women : A -interrupted closure of subcutaneous tissue with drain ( a closed nonvacuum drain was inserted in the tissue and exite from the skin through a separate opening and stitch to the skin) .
Read more
B-interrupted closure of subcutaneous tissue without drain. c- non closure of subcutaneous tissue with drain only. d- non closure of subcutaneous tissue without drain.
All womenu nder going CS with Pfannenstiel incision were considered to be eligible if time allowed informed consent before the surgery
Read the detailed description
Randomised cinical trial in Kasr Alainy Hospital.352 obese women pregnant with gestational age >38 wk ,their age range from (25-35) years and BMI between (30 -40) undergoing elective cesarean section were randomised into 3 groups (100 patients in each group)and compare the role of subcutaneous tissue closure in post cesarean section wound complications.
4 groups are:: A -interrupted closure of subcutaneous tissue with drain ( a closed nonvacuum drain was inserted in the tissue and exit from the skin through a separate opening and stitch to the skin) .
B-interrupted closure of subcutaneous tissue without drain. c- non closure of subcutaneous tissue with drain only. d- non closure of subcutaneous tissue without drain.
All women under going CS with Pfannenstiel incision were considered to be eligible if time allowed informed consent before the surgery All surgical procedures were performed by obstetric and gynecology residents under the supervision of attending physicians After the sequential closure of the uterus and peritoneum, the fascia was closed with 2-0 polyglactin 910 (Vicryl). The depth of the subcutaneous adipose tissue was measured with a sterile ruler from the fascia to the skin edge at the middle of the superior aspect of the skin incision.Women with a subcutaneous tissue thickness of 4.0 cm or more were then formally enrolled and randomized to one of the two subcutaneous closure techniques. Subcutaneous hemostasis were achieved using electrocautery and skin was approximated with subcuticular suture using 2-0 polyglactin910 (VicrylRapide).company city country In the drain group, a closed nonvacuum drain was inserted in the tissue and exite from the skin through a separate opening and stitch to the skin (Al Allair 2000). company city country The drain was left until the drainage rate was less than 30 ml/day or after 72h .( The skin was closed with a continuous nonabsorbable polypropylene 2/0 (Acufirm; Ernst Kratz, Germany) subcuticular sutures. Operative time was estimated from the start of skin incision until the end of skin suturing. The drain was left until the drainage rate was less than 50 ml/day.
All randomized women received standard postoperative wound care. Surgical dressing was removed on the first postoperative and all participants were discharged 24 h after the CS. The participants were invited to two follow-up in the first and second week post operative with regard to postoperative pain, postoperative fever, hospital stay duration, wound infection, wound seroma, wound disruption, and the need for redressing. The postoperative pain was judged after 24 h using visual analogue scale, in addition any time clinically indicated. Patients and physicians who assessed the incision postoperatively were blinded towards the study group.
- Conditions
- Wound Infection
- Being tested
- Cesarean section, subcutanous sutures, subcutanous drain
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean sectionProcedure or surgery
- Abdominal Incision: Pfannenstiel incision Sharp dissection will be continued through the subcutaneous layer to the fascia.
- The fascia will be then incised sharply at the midline
- The transversalis fascia and pre peritoneal fat will be dissected carefully
- The peritoneum will be then incised.
- Low Transverse Cesarean Incision. Bladder flap creation effectively moves the bladder away from the planned hysterotomy site
- Delivery of the Fetus and placenta.
- Uterine Repair in two layers of continuous 0-or No.1 absorbable suture.
subcutanous suturesProcedure or surgery
suture closure of subcutaneous tissue with interrupted 2-0 polyglactin 910 (Vicryl).the stitch interval is 1cm
subcutanous drainDevice
Inthedraingroup,aclosednonvacuum drain willbeinsertedin thetissueandexitefrom theskinthroughaseparateopeningandstitchto theskin
| Study group | Role | What they receive |
|---|---|---|
| interrupted closure of subcutaneous tissue with drain | Active comparator | consist of 89 patients that will be allocated for interrupted closure of subcutaneous tissue with drain Receives: Procedure: Cesarean section; Procedure: subcutanous sutures; Device: subcutanous drain |
| interrupted closure of subcutaneous tissue without dra | Active comparator | consist of 88 patients that will be allocated for interrupted closure of subcutaneous tissue without drain Receives: Procedure: Cesarean section; Procedure: subcutanous sutures |
| non closure of subcutaneous tissue with drain | Active comparator | In the drain group,a closed non vacuum drain will be inserted in the tissue and exit from the skin through a separate opening and stitch to the skin Receives: Procedure: Cesarean section; Device: subcutanous drain |
| non closure of subcutaneous tissue and no drain | Active comparator | 87 women without subcutanous sutures and without drain Receives: Procedure: Cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound infection
subjective evaluation of wound redness, seroma and induration
Measured: 2-8 weeks after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start4 Mar 2021
- Primary completion11 Sep 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- ahmed maged, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177381
- Sponsor's protocol ID
- 171
- Status last verified
- Jun 2025
- First submitted
- 21 Nov 2019
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shalaby MA, Metwally HHM, Maged AM, Bayoumi YA, Salah N. The value of subcutaneous tissue closure and drain in obese women undergo elective caesarean section: a randomized controlled trial. BMC Pregnancy Childbirth. 2025 May 5;25(1):534. doi: 10.1186/s12884-025-07579-z.
PubMed 40325365
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Subcutaneous Tissue Closure Versus Drain in Obese Women Undergo Elective Cesarean Section Arandomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04177381
- Acronym / sponsor ID
- 171
- Conditions
- Wound Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 11 Sep 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 26 Nov 2019 (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.
Randomised cinical trial in Kasr Alainy Hospital.352 obese women pregnant with gestational age >38 wk ,theire age range from (25-35) years and BMI between (30 -40) undergoing elective cesarean section were randomised into 4 groups and compare the role of subcutaneous tissue closure in post cesarean section wound complications.
groups are: 4 groups each group was 86 women : A -interrupted closure of subcutaneous tissue with drain ( a closed nonvacuum drain was inserted in the tissue and exite from the skin through a separate opening and stitch to the skin) .
B-interrupted closure of subcutaneous tissue without drain. c- non closure of subcutaneous tissue with drain only. d- non closure of subcutaneous tissue without drain.
All womenu nder going CS with Pfannenstiel incision were considered to be eligible if time allowed informed consent before the surgery
Detailed description
Randomised cinical trial in Kasr Alainy Hospital.352 obese women pregnant with gestational age >38 wk ,their age range from (25-35) years and BMI between (30 -40) undergoing elective cesarean section were randomised into 3 groups (100 patients in each group)and compare the role of subcutaneous tissue closure in post cesarean section wound complications.
4 groups are:: A -interrupted closure of subcutaneous tissue with drain ( a closed nonvacuum drain was inserted in the tissue and exit from the skin through a separate opening and stitch to the skin) .
B-interrupted closure of subcutaneous tissue without drain. c- non closure of subcutaneous tissue with drain only. d- non closure of subcutaneous tissue without drain.
All women under going CS with Pfannenstiel incision were considered to be eligible if time allowed informed consent before the surgery All surgical procedures were performed by obstetric and gynecology residents under the supervision of attending physicians After the sequential closure of the uterus and peritoneum, the fascia was closed with 2-0 polyglactin 910 (Vicryl). The depth of the subcutaneous adipose tissue was measured with a sterile ruler from the fascia to the skin edge at the middle of the superior aspect of the skin incision.Women with a subcutaneous tissue thickness of 4.0 cm or more were then formally enrolled and randomized to one of the two subcutaneous closure techniques. Subcutaneous hemostasis were achieved using electrocautery and skin was approximated with subcuticular suture using 2-0 polyglactin910 (VicrylRapide).company city country In the drain group, a closed nonvacuum drain was inserted in the tissue and exite from the skin through a separate opening and stitch to the skin (Al Allair 2000). company city country The drain was left until the drainage rate was less than 30 ml/day or after 72h .( The skin was closed with a continuous nonabsorbable polypropylene 2/0 (Acufirm; Ernst Kratz, Germany) subcuticular sutures. Operative time was estimated from the start of skin incision until the end of skin suturing. The drain was left until the drainage rate was less than 50 ml/day.
All randomized women received standard postoperative wound care. Surgical dressing was removed on the first postoperative and all participants were discharged 24 h after the CS. The participants were invited to two follow-up in the first and second week post operative with regard to postoperative pain, postoperative fever, hospital stay duration, wound infection, wound seroma, wound disruption, and the need for redressing. The postoperative pain was judged after 24 h using visual analogue scale, in addition any time clinically indicated. Patients and physicians who assessed the incision postoperatively were blinded towards the study group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| interrupted closure of subcutaneous tissue with drain | Active comparator | Procedure: Cesarean section, Procedure: subcutanous sutures, Device: subcutanous drainconsist of 89 patients that will be allocated for interrupted closure of subcutaneous tissue with drain |
| interrupted closure of subcutaneous tissue without dra | Active comparator | Procedure: Cesarean section, Procedure: subcutanous suturesconsist of 88 patients that will be allocated for interrupted closure of subcutaneous tissue without drain |
| non closure of subcutaneous tissue with drain | Active comparator | Procedure: Cesarean section, Device: subcutanous drainIn the drain group,a closed non vacuum drain will be inserted in the tissue and exit from the skin through a separate opening and stitch to the skin |
| non closure of subcutaneous tissue and no drain | Active comparator | Procedure: Cesarean section87 women without subcutanous sutures and without drain |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- obese women who BMI(30- 40 kg/m2)
- Gestational age (37-41) week calculated by sure dates and confirmed by first trimester US,
- single fetus.
- Elective lower segment cesarean section
Key exclusion criteria (10 listed)
- Any medical disorders affect wound healing as:
- Diabetes mellitus.
- On steroids.
- Immunedeficiency.
- Hypoalbuminemia.
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 |
|---|---|---|
| Cesarean section1. Abdominal Incision: Pfannenstiel incision Sharp dissection will be continued through the subcutaneous layer to the fascia. 2. The fascia will be then incised sharply at the midline 3. The transversalis fascia and pre peritoneal fat will be dissected carefully 4. The peritoneum will be then incised. 5. Low Transverse Cesarean Incision. Bladder flap creation effectively moves the bladder away from the planned hysterotomy site 6. Delivery of the Fetus and placenta. 7. Uterine Repair in two layers of continuous 0-or No.1 absorbable suture. | Procedure or surgery | interrupted closure of subcutaneous tissue with drain, interrupted closure of subcutaneous tissue without dra, non closure of subcutaneous tissue and no drain, non closure of subcutaneous tissue with drain |
| subcutanous suturessuture closure of subcutaneous tissue with interrupted 2-0 polyglactin 910 (Vicryl).the stitch interval is 1cm | Procedure or surgery | interrupted closure of subcutaneous tissue with drain, interrupted closure of subcutaneous tissue without dra |
| subcutanous drainInthedraingroup,aclosednonvacuum drain willbeinsertedin thetissueandexitefrom theskinthroughaseparateopeningandstitchto theskin | Device | interrupted closure of subcutaneous tissue with drain, non closure of subcutaneous tissue with drain |
Primary outcome
wound infection
Time frame: 2-8 weeks after the operation
subjective evaluation of wound redness, seroma and induration
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 25 Jun 2025.
- Derived from this study: PubMed 40325365Shalaby MA, Metwally HHM, Maged AM, Bayoumi YA, Salah N. The value of subcutaneous tissue closure and drain in obese women undergo elective caesarean section: a randomized controlled trial. BMC Pregnancy Childbirth. 2025 May 5;25(1):534. doi: 10.1186/s12884-025-07579-z.
- 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.
ahmed maged study director
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cesarean section, subcutanous sutures and subcutanous drain in people with Wound Infection, run by Cairo 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 4 inclusion and 10 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 25 Jun 2025. 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?
wound infection (time frame: 2-8 weeks after the operation). 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 NCT04177381, which also lists 1 linked publication.
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 25 Jun 2025.