Cesarean SectionNCT07846930
Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²
An observational study of Cesarean Section and Surgical Wound Infection, run by Assiut University.
Trial summary
Cesarean delivery is one of the most common surgical procedures in obstetric care. Women with obesity (body mass index [BMI] of 30 kg/m² or higher) are at increased risk for postoperative wound complications, including surgical site infections, fluid collections (seroma/hematoma), and wound separation. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Cesarean Section, Surgical Wound Infection, Wound Healing
- How many people
- 726 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- Adult
Study population: Pregnant women aged 18 to 35 years with a body mass index (BMI) ≥ 30 kg/m² undergoing cesarean delivery via a Pfannenstiel skin incision at the Department of Obstetrics and Gynecology, Assiut University Hospitals, and Malawi Specialized Hospital.
Who may be able to join
- Women aged 18 to 35 years
- Body mass index (BMI) ≥ 30 kg/m² measured before cesarean delivery or at admission
- Undergoing cesarean delivery with a Pfannenstiel skin incision and primary skin closure
Who cannot join
- Pre-existing infection or inflammation at the planned incision site
- Active systemic infection or fever prior to surgery
- Clinical or subclinical chorioamnionitis
- Major intraoperative contamination of the surgical field
- Significant preoperative bleeding or anemia
- Known bleeding or coagulation disorders that may significantly affect wound healing
- Major postoperative complications requiring additional abdominal surgery
- Inability or unwillingness to attend scheduled follow-up visits
About this study
Official title: Effect of Cesarean Wound Dressing Removal Timing on Wound Healing in Women With BMI ≥ 30 kg/m²
Cesarean delivery is one of the most common surgical procedures in obstetric care. Women with obesity (body mass index [BMI] of 30 kg/m² or higher) are at increased risk for postoperative wound complications, including surgical site infections, fluid collections (seroma/hematoma), and wound separation. Postoperative wound dressings protect the surgical incision, but the optimal timing for dressing removal remains uncertain, particularly for high-risk patients.
The purpose of this prospective cohort study is to compare wound healing and the occurrence of surgical site infections between two standard dressing removal schedules in women with a BMI ≥ 30 kg/m² undergoing cesarean delivery.
Read more
Participants are observed in one of two groups according to standard hospital practice:
- Group 1: The sterile wound dressing is removed at approximately 48 hours after surgery.
- Group 2: The sterile wound dressing is removed at approximately 5 days after surgery.
Following dressing removal, incisions are assessed for signs of infection, drainage, swelling, and healing progress. The study aims to provide evidence on whether earlier dressing removal at 48 hours is safe and effective compared to delayed removal at 5 days in women with obesity.
- Conditions
- Cesarean Section, Surgical Wound Infection, Wound Healing, Obesity, Surgical Wound Dehiscence
- Keywords
- Cesarean delivery, Wound dressing, Dressing removal timing, Surgical site infection, Pfannenstiel incision, Postoperative care, Maternal obesity, Wound complications
- Medical subject headings
- Surgical Wound Infection, Obesity, Surgical Wound Dehiscence, Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 48-Hour Dressing Removal | Women with BMI ≥ 30 kg/m² undergoing cesarean delivery with a Pfannenstiel skin incision whose standardized sterile wound dressing is removed at approximately 48 hours after surgery, followed by clinical wound inspection under aseptic conditions and routine postoperative care. | |
| 5-Day Dressing Removal | Women with BMI ≥ 30 kg/m² undergoing cesarean delivery with a Pfannenstiel skin incision whose standardized sterile wound dressing is removed at approximately 5 days after surgery, followed by clinical wound inspection under aseptic conditions and routine postoperative care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Surgical Site Infection (SSI)
Number of participants diagnosed with a surgical site infection (SSI) at the Pfannenstiel incision site. Assessment is performed using a standardized clinical wound-assessment form evaluating the presence of purulent discharge, localized erythema, heat, edema, or wound separation.
Measured: Up to 48 hours after dressing removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 726 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Tawfik Abdelmalek Gomaa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846930
- Sponsor's protocol ID
- Cesarean Wound Dressing Timing
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cesarean Wound Dressing Removal Timing on Wound Healing in Women With BMI ≥ 30 kg/m²
- ClinicalTrials.gov ID
- NCT07846930
- Acronym / sponsor ID
- Cesarean Wound Dressing Timing
- Conditions
- Cesarean Section, Surgical Wound Infection, Wound Healing, Obesity, Surgical Wound Dehiscence
- Keywords
- Cesarean delivery, Wound dressing, Dressing removal timing, Surgical site infection, Pfannenstiel incision, Postoperative care, Maternal obesity, Wound complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 726 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 29 Sep 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.
Cesarean delivery is one of the most common surgical procedures in obstetric care. Women with obesity (body mass index [BMI] of 30 kg/m² or higher) are at increased risk for postoperative wound complications, including surgical site infections, fluid collections (seroma/hematoma), and wound separation. Postoperative wound dressings protect the surgical incision, but the optimal timing for dressing removal remains uncertain, particularly for high-risk patients.
The purpose of this prospective cohort study is to compare wound healing and the occurrence of surgical site infections between two standard dressing removal schedules in women with a BMI ≥ 30 kg/m² undergoing cesarean delivery.
Participants are observed in one of two groups according to standard hospital practice:
- Group 1: The sterile wound dressing is removed at approximately 48 hours after surgery.
- Group 2: The sterile wound dressing is removed at approximately 5 days after surgery.
Following dressing removal, incisions are assessed for signs of infection, drainage, swelling, and healing progress. The study aims to provide evidence on whether earlier dressing removal at 48 hours is safe and effective compared to delayed removal at 5 days in women with obesity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 48-Hour Dressing Removal | – | –Women with BMI ≥ 30 kg/m² undergoing cesarean delivery with a Pfannenstiel skin incision whose standardized sterile wound dressing is removed at approximately 48 hours after surgery, followed by clinical wound inspection under aseptic conditions and routine postoperative care. |
| 5-Day Dressing Removal | – | –Women with BMI ≥ 30 kg/m² undergoing cesarean delivery with a Pfannenstiel skin incision whose standardized sterile wound dressing is removed at approximately 5 days after surgery, followed by clinical wound inspection under aseptic conditions and routine postoperative care. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women aged 18 to 35 years with a body mass index (BMI) ≥ 30 kg/m² undergoing cesarean delivery via a Pfannenstiel skin incision at the Department of Obstetrics and Gynecology, Assiut University Hospitals, and Malawi Specialized Hospital.
Key inclusion criteria (3 listed)
- Women aged 18 to 35 years
- Body mass index (BMI) ≥ 30 kg/m² measured before cesarean delivery or at admission
- Undergoing cesarean delivery with a Pfannenstiel skin incision and primary skin closure
Key exclusion criteria (8 listed)
- Pre-existing infection or inflammation at the planned incision site
- Active systemic infection or fever prior to surgery
- Clinical or subclinical chorioamnionitis
- Major intraoperative contamination of the surgical field
- Significant preoperative bleeding or anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Surgical Site Infection (SSI)
Time frame: Up to 48 hours after dressing removal
Number of participants diagnosed with a surgical site infection (SSI) at the Pfannenstiel incision site. Assessment is performed using a standardized clinical wound-assessment form evaluating the presence of purulent discharge, localized erythema, heat, edema, or wound separation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section and Surgical Wound Infection, run by Assiut University.
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 8 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Participants With Surgical Site Infection (SSI) (time frame: Up to 48 hours after dressing removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.