IS ADDITION OF IRRIGATION OF WOUND WITH NORMAL SALINE TO VACUUM THERPAY MORE EFFECTIVE IN HEALING OF EXTREMITY ULCER COMPARED TO CONVENTIONAL VACUUM THERAPY

COMPARISON OF CONVENTIONAL NEGATIVE PRESSURE WOUND THERAPY WITH NEGATIVE PRESSURE WOUND THERAPY WITH NORMAL SALINE INSTILLATION IN THE HEALING OF EXTREMITY WOUNDS: A RANDOMIZED CONTROLLED TRIAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/025410

Enrollment

Registered

2020-05-28

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: S818- Open wound of lower leg

Interventions

Intervention1: Negative Pressure Wound Therapy with Normal Saline Instillation: intermittent instillation of normal saline in addition to conventional NPWT given four times a day every fourth hourly w

Eligibility

Inclusion criteria

Inclusion criteria: extremity ulcer

Exclusion criteria

Exclusion criteria: 1. Patients with uncontrolled hyperglycaemia (HbA1c > 12%) 2. Patients with peripheral vascular disease 3. Patients on concomitant drug therapy such as immunosuppressant, corticosteroids. 4.Patients with underlying malignancy 5. Active necrotising fasciitis 6. Wounds with open joint capsules

Design outcomes

Primary

Measure	Time frame
Wound contracture Timepoint: Wound surface area on day 1 and day 10	—

Secondary

Measure	Time frame
Bacterial burden of the wound assessed quantitatively (colony forming units) and qualitatively; microscopic markers of wound healing by assessing various histological parameters such as change in surface epithelium, histological appearance of granulation tissue, reduction in inflammatory cells, improvement in proliferating blood vessels and fibroblastic reaction and change in adnexal structuresTimepoint: all parameters assessed on first day (day1) at the initiation of intervention and repeated on day 10 after the intervetnion period (intervention period of 10 days)	—

Measure

Time frame

Bacterial burden of the wound assessed quantitatively (colony forming units) and qualitatively; microscopic markers of wound healing by assessing various histological parameters such as change in surface epithelium, histological appearance of granulation tissue, reduction in inflammatory cells, improvement in proliferating blood vessels and fibroblastic reaction and change in adnexal structuresTimepoint: all parameters assessed on first day (day1) at the initiation of intervention and repeated on day 10 after the intervetnion period (intervention period of 10 days)

—

Countries

India

Contacts

Public ContactPrakriti Giri

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

drbalak@gmail.com8098116013

Outcome results

None listed

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