Abdominal Midline Wound Closure: Small Tissue Bites Versus Large Tissue Bites
The goal of this clinical trial is to learn whether a small stitch technique works better than a large bite technique for closing midline abdominal surgery wounds in adults having midline laparotomy surgery.
The main questions it aims to answer are:
Does the small stitch technique lower the risk of surgical site infection? Does the small stitch technique lower the risk of wound dehiscence (reopening of the wound)? Researchers will compare the small stitch technique with the large bite technique to see if the small stitch technique leads to fewer wound complications after surgery.
Participants will:
Have their abdominal wound closed using either the small stitch or large bite technique during surgery Attend follow-up visits at 2 weeks and 1 month after surgery Be checked for wound complications, including infection and wound reopening In the small stitch technique, stitches are placed 5 millimeters from the wound edge and 5 millimeters apart. In the large bite technique, stitches are placed 10 millimeters apart.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This clinical trial is designed to evaluate two different methods of closing abdominal wounds after midline laparotomy surgery in adults. A midline laparotomy is a common surgical procedure in which an incision is made along the middle of the abdomen to allow surgeons access to internal organs. Proper closure of this incision is important because complications such as infection or reopening of the wound can lead to pain, delayed recovery, longer hospital stays, and additional treatment.
The study focuses on comparing a "small stitch" technique with the more traditional "large bite" technique used to close the abdominal wall at the end of surgery. Researchers want to determine whether the small stitch method can improve healing and reduce complications after surgery.
In the small stitch technique, sutures are placed approximately 5 millimeters from the edge of the wound and spaced 5 millimeters apart. This approach is designed to distribute tension more evenly across the wound and may help preserve blood supply to the tissues, potentially improving healing. In the large bite technique, stitches are placed farther from the wound edge and farther apart, which is the conventional method commonly used in many surgical settings.
The main goals of the study are to determine:
Whether the small stitch technique reduces the risk of surgical site infections Whether the small stitch technique lowers the chance of wound dehiscence, a serious complication in which the surgical wound partially or completely reopens after surgery Adults undergoing midline laparotomy surgery may be eligible to participate. During the procedure, participants will have their abdominal incision closed using either the small stitch or the large bite technique. The method used will be assigned according to the study protocol so that researchers can fairly compare outcomes between the two groups.
After surgery, participants will continue with routine postoperative care and attend follow-up visits approximately 2 weeks and 1 month after their operation. At these visits, the surgical wound will be examined for signs of infection, delayed healing, wound reopening, pain, or other complications. Researchers will collect and compare the results from both groups to determine which closure method provides better outcomes.
The information gained from this study may help surgeons identify the safest and most effective way to close abdominal incisions, potentially improving recovery and reducing postoperative complications for future patients undergoing abdominal surgery.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Karachi, Pakistan, 75510
- Indus Hospital and Health Network
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
. Age 18-80 years, either sex
- Midline laparotomy (elective or emergency)
- ASA class I-IV
Exclusion Criteria:
- Previous incisional hernia or midline incision
- Contaminated surgery
- ASA V-VI
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Small Stitch Closure Technique
Participants in this arm will undergo abdominal wall closure using the small stitch technique following midline laparotomy surgery.
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In this technique, sutures are placed approximately 5 millimeters apart using a continuous suturing method.
Autres noms:
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Comparateur actif: Large Stitch Closure Technique
Participants in this arm will undergo abdominal wall closure using the large stitch technique following midline laparotomy surgery
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In this technique, sutures are placed approximately 10 millimeters apart using a continuous suturing method.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Sheath Dehiscence
Délai: 30 days
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Abdominal fascial (sheath) dehiscence, defined as partial or complete separation of the abdominal fascial closure with or without evisceration, assessed by clinical examination of the surgical wound by the treating surgical team.
The outcome will be reported as the number of participants who develop fascial dehiscence during the follow-up period.
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30 days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Skin dehiscence
Délai: 30 days
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Postoperative skin wound dehiscence, defined as partial or complete separation of the skin edges of the surgical incision, assessed by standardized clinical wound examination performed during postoperative follow-up.
The outcome will be reported as the number of participants who develop skin wound dehiscence.
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30 days
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Southampton wound grading
Délai: 30 days
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normal healing, erythema, discharge, purulence
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30 days
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Nazia Lodhi, MBBS, FCPS, Indus Hospital and Health Network
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Autres numéros d'identification d'étude
- IHHN_IRB_2024_03_014
Informations sur les médicaments et les dispositifs, documents d'étude
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