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Study to see if the infection of the operation site or of the mesh used for hernia repair is reduced by changing the gloves during the operation just before using the mesh during the surgery for hernia repair with a mesh.

A randomized controlled trial to assess the effect of changing gloves immediately prior to mesh handling in reducing the surgical site infection rates among patients undergoing glove change versus patients in whom no such change has been undertaken during elective open mesh hernioplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/032285
Enrollment
630
Registered
2021-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R190- Intra-abdominal and pelvic swelling, mass and lump

Interventions

Intervention1: Intervention group _ Intraoperative glove change prior to mesh handling: Intraoperative glove change of the surgeon,assistants and scrub nurse prior to handling mesh in intervention gro

Sponsors

Chetan Anand
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing elective open mesh hernioplasty and consenting to be a study participant.

Exclusion criteria

Exclusion criteria: 1.Patients aged 2.Recurrent hernia Surgery 3.Patientâ??s with inflammed,obstructed or strangulated hernia.

Design outcomes

Primary

MeasureTime frame
Surgical site infection or mesh infection within a year from the date of surgeryTimepoint: everyday of the inpatient stay period, postoperative day 07, postoperative day 14, postoperative 01 month, postoperative 06 month, postoperative 01 year, any other time within a year after surgery if patient presents with symptoms and signs of surgical site or mesh infection.

Secondary

MeasureTime frame
1.Intraoperative incidence of glove perforation 2.Intraoperative contamination by microorganisms of the gloves worn during surgery by culturing the glove index finger tip and cuff worn by the operating surgeon Timepoint: Intraoperatively - perforation of gloves checked at the time of intraoperative glove change prior to mesh handling in the intervention group and at the end of surgery at the time of degloving in the comparator group. Dominant hand gloves (outer glove in case of use of double gloves) index finger tip of the operating surgeon and cuff of the operating surgeon is sent for culture at the time of glove change in intervention group and at the time of degloving in the comparator group.

Countries

India

Contacts

Public ContactChetan Anand

AIIMS, RAIPUR

drchetananand@aiimsraipur.edu.in08489161712

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026