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Evaluating the safety and feasibility of early separation of pedicled flaps from its source

EARLY Vs. CONVENTIONAL DIVISION OF PEDICLED FLAPS: A PROPSECTIVE RANDOMIZED CONTROLLED STUDY

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017353
Enrollment
70
Registered
2019-01-31
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: S672- Crushing injury of hand

Interventions

Intervention1: Early division of pedicled flaps: The flaps will be assessed for adequacy of perfusion on the 7th postoperative day by clinical and thermographic methods ï?? If the flap perfusion is fo

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of age >=15 years undergoing reconstructive procedure using all types of pedicled flaps 2.Presence of atleast 50% of the wound bed with well vascularized tissue 3.Flaps which have atleast 50 % inset onto the recipient site

Exclusion criteria

Exclusion criteria: 1.Flaps with inadequate inset 2.Absence of atleast 50% well vascularized tissue in the bed 3.Unsatisfactory perfusion of the flap at 24 hours 4.Flaps with smaller surface area such as cross- finger flaps, abbe flaps etc. • Refusal to give consent • Age • Presence of any psychiatric or neurological illness • Pregnant patients • ASA class 3 or 4a • Patients with history of vascular disease(vasculitis, microangipathy etc) • Patients undergoing flap revision surgery

Design outcomes

Primary

MeasureTime frame
Flap survival at 10 days (Flap survival will be defined as absence of any vascular compromise or signs of flap failure)Timepoint: 10th day

Secondary

MeasureTime frame
â?¢ Morbidity parameters(flap failure, necrosis, dehiscence, wound complications, need for re-operation)Timepoint: upto 6 weeks;â?¢ Presence of joint stiffness and skin maceration in the regions adjoining recipient siteTimepoint: 6 weeks;Day of complete insetTimepoint: 12th day;Day of division of the flap Timepoint: 10th day;Length of hospitalization(LOH)Timepoint: days;Quality of life and function(VAS score)Timepoint: at time of inset,3 weeks and at 6 weeks post operatively

Countries

India

Contacts

Public ContactJerry R John

Postgraduate Institute Of Medical Education and Research(PGIMER)

jerryrjohn@hotmail.com9872295768

Outcome results

None listed

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