- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07846930
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.
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
|---|
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants With Surgical Site Infection (SSI)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Complications postopératoires
- Processus pathologiques
- Troubles nutritionnels
- Maladies urogénitales féminines et complications de la grossesse
- Suralimentation
- Poids
- Complications de grossesse
- Infections
- En surpoids
- Infection de la plaie
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- Obésité
- Infection de plaie chirurgicale
- Déhiscence chirurgicale des plaies
- Grossesse dans l'obésité
Autres numéros d'identification d'étude
- Cesarean Wound Dressing Timing
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