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Effect of surgical in below knee amputations in diabetics in preventing surgical site infections

Examining the Impact of Drain vs No drain on surgical site infection in below knee amputation in diabetics: A comparative study at AIIMS Raipur - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075345
Enrollment
56
Registered
2024-10-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: E115- Type 2 diabetes mellitus with circulatory complications

Interventions

Intervention1: Below knee amputation with drain: placement of negative suction drain in the subfascial plane Control Intervention1: Below knee amputation with out drain: No placement of drain after be

Sponsors

All India Institute of Medical Sciences, Raipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient with diabetes presenting to Aiims raipur with indication of below knee lower limb amputatation All patients who give informed consent for the study

Exclusion criteria

Exclusion criteria: Patients who undergo Guillotine type of lower limb amputation Patients undergoing above knee amputations Patients undergoing amputations due to any other cause instead of diabetes

Design outcomes

Primary

MeasureTime frame
To assess and compare the incidence of surgical site infections in patients undergoing lower limb amputation surgeries, with a focus on those randomized to receive drains versus those randomized to a no- drain approach.Timepoint: 31 Days

Secondary

MeasureTime frame
To analyze the time to onset of surgical site infections between the drain and no-drain groups. To evaluate wound healing outcomes and complications in both groups. To assess patient-reported outcomes, including pain levels and satisfaction, following lower limb amputation surgeries with and without drains.Timepoint: 31 days

Countries

India

Contacts

Public ContactDr Tridip Dutta Baruah

All India Institute of Medical Sciences, Raipur

tridipduttabaruah@gmail.com9109720246

Outcome results

None listed

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