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BENEFITS OF VAC DRESSING OVER STANDARD DRESSING AFTER AMPUTATION

PROPHYLACTIC USE OF INCISIONAL NEGATIVE PRESSURE WOUND THERAPY VERSUS STANDARD DRESSING AFTER MAJOR LIMB AMPUTATION, A RANDOMISED CONTROLLED TRIAL.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031166
Enrollment
50
Registered
2021-02-10
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: I00-I99- Diseases of the circulatory system

Interventions

Intervention1: negative wound pressure therapy: negative wound pressure therapy or vacuum assisted closure device will applied over the amputated stumps for 5 days postoperatively, only once Control I

Sponsors

VADDAVALLI VENKATA VINEETH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with gangrene due to peripheral artery disease in lower limbs and would require major amputation (Below knee and above knee amputations). 2. Patients with below knee amputation should have at least one tibial artery outflow after revascularization or patent to have adequate supply for stump healing. 3. Patients with above knee amputation should have profunda femoris patent for adequate healing (confirmed by imaging arterial duplex or computed tomography)

Exclusion criteria

Exclusion criteria: 1. patient with inadequate lower extremity perfusion were not enrolled 2. patients with uncontrolled hyperglycemia ( A1c > 12) 3. Amputation in patients with collagen vascular disease, ulcer malignancy, and untreated osteomyelitis 4. Patients who were not able walk due to previous stroke will be excluded 5. Patients who has developed contracture and will require surgery for it will be excluded. 6. Patients underwent guillotine amputation will be excluded

Design outcomes

Primary

MeasureTime frame
Wound infection, Stump dehiscence, Seroma/hematoma formation,Need for re-amputation Timepoint: 2 months

Secondary

MeasureTime frame
Complete healing of the stump,Eligibility for prosthesis placement or rehabilitation Timepoint: 2 months

Countries

India

Contacts

Public ContactDr Ajay Savlania

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH

vineeth1126@gmail.com

Outcome results

None listed

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