NCT07205939

Brief Summary

This study aims to investigate surgical site monitoring after cesarean section using a mobile application currently being developed. This mobile application aims to facilitate early diagnosis of surgical site infection, reduce clinic visits for wound monitoring, and consequently reduce labor, travel, and care costs. In this context, a randomized controlled design will be conducted between the study and control groups to compare surgical site infection rates, time to diagnosis, number of clinic visits, frequency of hospitalization, care costs, and patient satisfaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2026

Completed
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

September 25, 2025

Last Update Submit

February 28, 2026

Conditions

Surgical InfectionCesarean Section Wound

Keywords

mobile applicationcesarean sectionsurgical site infection

Outcome Measures

Primary Outcomes (1)

  • Surgical Site Infection (SSI) within 30 days (CDC criteria)

    SSI status adjudicated per CDC criteria by a blinded outcomes assessor.

    30 days post-cesarean

Study Arms (2)

Standard Care (Usual Care) - routine postpartum wound care instructions and scheduled follow-up.

NO INTERVENTION

Mobile App Telemonitoring + Standard Care

EXPERIMENTAL
Device: Mobile Application usage

Interventions

Mobile Application usageDEVICE

Articipants complete a brief symptom questionnaire and upload a standardized photo of the cesarean incision on postpartum days 3, 7, and 15 (±1 day) via the study mobile platform. Patients will be reminded remotely on these mandatory days. They will be informed that if they have concerns about the wound outside of these mandatory days, they can use the app and share their survey and image data. The surveys and images uploaded to the app will be evaluated by the researcher and reviewed by a clinician. Retakes will be requested for photos that are not of sufficient quality for evaluation. Clinical recommendations after review will be based on the patient's reported symptoms, and the wound images will provide additional information on this topic. One month after the cesarean section, all participants will be contacted by the researcher. They will be asked about the current status of their wounds and a patient satisfaction survey will be administered.

Also known as: SurgiMomma
Mobile App Telemonitoring + Standard Care

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women who have had a Caesarean section
  • Aged between 18 and 45 years
  • Own a smartphone with internet access
  • Provide informed consent
  • Have adequate Turkish reading comprehension

You may not qualify if:

  • Presence of illnesses that prevent the use of the online survey or application (e.g., visual impairment, neuropsychiatric illness)
  • Failure to comply with study procedures (e.g., incomplete or missing forms)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Rochon M, Jawarchan A, Fagan F, Otter JA, Tanner J. Image-based digital post-discharge surveillance in England: measuring patient enrolment, engagement, clinician response times, surgical site infection, and carbon footprint. J Hosp Infect. 2023 Mar;133:15-22. doi: 10.1016/j.jhin.2023.01.001. Epub 2023 Jan 13.

    PMID: 36642336RESULT

  • McLean KA, Sgro A, Brown LR, Buijs LF, Daines L, Potter MA, Bouamrane MM, Harrison EM. Evaluation of remote digital postoperative wound monitoring in routine surgical practice. NPJ Digit Med. 2023 May 5;6(1):85. doi: 10.1038/s41746-023-00824-9.

    PMID: 37147462RESULT

  • McLean KA, Mountain KE, Shaw CA, Drake TM, Pius R, Knight SR, Fairfield CJ, Sgro A, Bouamrane M, Cambridge WA, Lyons M, Riad A, Skipworth RJE, Wigmore SJ, Potter MA, Harrison EM; TWIST Collaborators. Remote diagnosis of surgical-site infection using a mobile digital intervention: a randomised controlled trial in emergency surgery patients. NPJ Digit Med. 2021 Nov 18;4(1):160. doi: 10.1038/s41746-021-00526-0.

    PMID: 34795398RESULT

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • SİBEL BULUT HAKLI

    Istinye University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

September 25, 2025

First Posted

October 3, 2025

Study Start

January 5, 2025

Primary Completion

January 20, 2026

Study Completion

February 5, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations

TU(1)