NCT07846930

Brief 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. 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
726

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Nov 2027

First Submitted

Initial submission to the registry

September 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Keywords

Cesarean deliveryWound dressingDressing removal timingSurgical site infectionPfannenstiel incisionPostoperative careMaternal obesityWound complications

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 48 hours after dressing removal

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Surgical Wound InfectionObesitySurgical Wound DehiscencePregnancy in Obesity

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

September 23, 2026

First Posted

September 29, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

September 29, 2026

Record last verified: 2026-09