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Abdominal Midline Wound Closure: Small Tissue Bites Versus Large Tissue Bites

1. juni 2026 oppdatert av: Indus Hospital and Health Network

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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

88

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Karachi, Pakistan, 75510
        • Indus Hospital and Health Network

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Small Stitch Closure Technique
Participants in this arm will undergo abdominal wall closure using the small stitch technique following midline laparotomy surgery.
In this technique, sutures are placed approximately 5 millimeters apart using a continuous suturing method.
Andre navn:
  • Small Bite Closure Technique
Aktiv komparator: Large Stitch Closure Technique
Participants in this arm will undergo abdominal wall closure using the large stitch technique following midline laparotomy surgery
In this technique, sutures are placed approximately 10 millimeters apart using a continuous suturing method.
Andre navn:
  • Large Bite Closure Technique

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sheath Dehiscence
Tidsramme: 30 days
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.
30 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Skin dehiscence
Tidsramme: 30 days
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.
30 days
Southampton wound grading
Tidsramme: 30 days
normal healing, erythema, discharge, purulence
30 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Nazia Lodhi, MBBS, FCPS, Indus Hospital and Health Network

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2025

Primær fullføring (Faktiske)

28. februar 2026

Studiet fullført (Faktiske)

30. mars 2026

Datoer for studieregistrering

Først innsendt

18. mai 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

2. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • IHHN_IRB_2024_03_014

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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