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To compare the outcome of two techniques- modified shoe-lacing and negative pressure wound therapy in achieving primary closure of fasciotomy wounds in trauma patients having lower limb compartment syndrome

â??To Compare the outcome of Modified Shoelace Technique versus Negative Pressure Wound Therapy (NPWT) assisted skin approximation of lower limb fasciotomy wounds in trauma patients â?? a Pilot Randomised Controlled Trial at a Level 1 Trauma Centreâ??

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049621
Enrollment
50
Registered
2023-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: MODIFIED SHOE LACE TECHNIQUE Max duration 14days: Modified shoe lacing will be done using braided polyester polyfilament no 2- Ethibond® no 2 sutures [Johnson & Johnson- Coated polyes
hours. Later on, the suture will be gradually tightened at an interval of every successive 24 hours bedside with or without aid of IV analgesia or sedation until the skin margins are LESS THAN 2 cm ap

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients undergoing two incision four compartment fasciotomy in lower limb for suspected or anticipated compartment irrespective of the underlying cause (lower limb long bone #, crush syndrome or proximal vascular injury with/ without vascular repair) 2• Adult patients in the age group 18 -65 years

Exclusion criteria

Exclusion criteria: 1• Patients with critical limb ischemia with doubtful limb salvageability (a)delayed capillary refill more than 3sec or b). spo2 LESS THAN 90%; c)sluggish or non-contractile, contused muscles; d) Presence of skin mottling)

Design outcomes

Primary

MeasureTime frame
To assess the rate of primary(delayed) closure of woundTimepoint: 14 days

Secondary

MeasureTime frame
To assess and compare the time taken (in days) to achieve primary (delayed) closure of fasciotomy wounds between the two techniques Timepoint: 14 days;to compare the rate of complications between two techniques (skin edge necrosis, uneven healing, contour deformities, paraesthesia, bleeding, wound infectionTimepoint: at follow up - after 2 weeks

Countries

India

Contacts

Public ContactDR DRISHTI BATRA

JPNATC, AIIMS

narendra3483@gmail.com9911850813

Outcome results

None listed

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