- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07926100
Recognizing and Reporting Surgical Wound Complications After Discharge From Gastrointestinal Surgery in Egypt (WOUND-REPORT)
Barriers and Enablers to Recognizing and Reporting Surgical Wound Complications After Hospital Discharge Following Gastrointestinal Surgery: A Multisite Qualitative Study of Patients, Caregivers, and Nurses to Inform Nurse-Led Remote Surveillance
Many wound problems after surgery on the digestive system, including wound infection, are first noticed after the patient has already gone home. Delays in noticing a problem and contacting the hospital can delay treatment. Existing studies come mostly from high-income countries and usually look at only one group of people. No study from Egypt or the Arabic-speaking region was found in the sources reviewed.
This qualitative study will explore what helps and what gets in the way when patients, family caregivers, and nurses recognize, report, and respond to surgical wound problems after discharge from gastrointestinal surgery. Individual semi-structured interviews will be held in Egyptian Arabic, in person or by telephone, at three hospitals in Egypt. The planned participants are 20 patients discharged 2 to 6 weeks earlier, 12 family caregivers, 15 nurses, and up to 4 key informants, for a planned total of 51. Participants will be chosen purposefully to include a wide range of experiences, and recruitment in each group will stop once further interviews bring no new themes.
Interviews will be analysed with reflexive thematic analysis, guided by the Common-Sense Model of Self-Regulation. The main result is a description of the barriers and enablers. Further results are a model of the pathway from noticing a wound change, to reporting it, to the nursing response, and a set of requirements for a nurse-led remote follow-up service.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Mohamed Fakhry Ahmed Salem, PhD
- Telefonnummer: 01286038014
- E-Mail: Mohamed.Fakhry@alexu.edu.eg
Studienorte
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Alexandria Governorate
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Alexandria, Alexandria Governorate, Ägypten, 2500
- Faculty of Nursing, Alexandria University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Adult patients discharged 2 to 6 weeks earlier after gastrointestinal surgery, their family caregivers, registered nurses, and key informants responsible for discharge or follow-up policy, at three hospitals in Egypt.
Beschreibung
Inclusion Criteria:
- Patients: age 18 years or older
- Patients: discharged 2 to 6 weeks before the interview after gastrointestinal surgery (colon, rectum, stomach, small bowel, liver and biliary tract, pancreas, gallbladder) with an abdominal wound (open or laparoscopic)
- Patients: Arabic-speaking
- Patients: able to give informed consent
- Family caregivers: age 18 years or older
- Family caregivers: the family member most involved in the patient's wound care or communication with the hospital after discharge
- Family caregivers: Arabic-speaking
- Nurses: registered nurses working in gastrointestinal or general surgical wards, discharge planning, or infection prevention at a study site
- Nurses: at least 1 year of surgical or infection-prevention experience
- Key informants: nursing managers, infection-control leads, or surgeons with responsibility for discharge or follow-up policy
Exclusion Criteria:
- Patients: cognitive impairment or inability to take part in an interview
- Patients: still hospitalized or readmitted at the time of interview
- Patients: day-case procedures without an abdominal wound requiring home care
- Family caregivers: paid or professional caregivers
- Nurses: on leave for the whole data collection period
- Nurses: in direct line management of the interviewer
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: OTHER
- Zeitperspektiven: CROSS_SECTIONAL
Kohorten und Interventionen
Gruppe / Kohorte |
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Patients
Adults (18 years or older) discharged 2 to 6 weeks before interview after gastrointestinal surgery with an abdominal wound; planned n = 20. Interviewed once. |
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Family Caregivers
Adult family member most involved in the patient's wound care or communication with the hospital after discharge; planned n = 12. Interviewed once. |
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Nurses
Registered nurses in gastrointestinal or general surgical wards, discharge planning, or infection prevention, with at least 1 year of experience; planned n = 15. Interviewed once. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Barriers and Enablers to Recognizing, Reporting, and Responding to Post-Discharge Surgical Wound Complications
Zeitfenster: Interviews from 10 November 2026 to 24 February 2027 (14 weeks), extendable by up to 4 weeks if the stopping rule is not met
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Individual, relational, and service-level barriers and enablers described by patients, caregivers, nurses, and key informants in semi-structured interviews and identified through reflexive thematic analysis. This is a qualitative outcome with no numeric scale; results are reported as themes. |
Interviews from 10 November 2026 to 24 February 2027 (14 weeks), extendable by up to 4 weeks if the stopping rule is not met
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Pathway Model From Noticing to Nursing Response
Zeitfenster: Through analysis, up to 31 March 2027
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Model of the stages of noticing a wound change, judging concern, reporting, nurse triage, and follow-up, built from the themes and mapped to the Common-Sense Model of Self-Regulation. |
Through analysis, up to 31 March 2027
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Mohamed Fakhry Ahmed Salem, PHD, Alexandria University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- GI-WOUND-QUAL-2026-01
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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