Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²
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.
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 Overview
Status
Status
Conditions
Conditions
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Up to 48 hours after dressing removal
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Postoperative Complications
- Pathologic Processes
- Nutrition Disorders
- Female Urogenital Diseases and Pregnancy Complications
- Overnutrition
- Body Weight
- Pregnancy Complications
- Infections
- Overweight
- Wound Infection
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Surgical Wound Infection
- Surgical Wound Dehiscence
- Pregnancy in Obesity
Other Study ID Numbers
Other Study ID Numbers
- Cesarean Wound Dressing Timing
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.