RANDOMISED CONTROL TRIAL TO COMPARE THE EFFICACY OF SHIRA MICROCLAMPS AND ACLAND MICROCLAMPS IN MICROVASCULAR ANASTOMOSIS

STUDY DESIGN
A single centre, parallel group, randomised control clinical trial on 30 patients requiring microvascular anastomosis. The selected patients were randomly divided into two groups:
Group 1, n=15 (Control): Microvascular anastomosis using Acland microclamp.
Group 2, n=15: Microvascular anastomosis using Shira microclamp.
PARTICIPANTS AND SETTING
The study was conducted in the Department of Plastic Surgery and Department of Maxillofacial Surgery, AIIMS Jodhpur. The randomisation was done using randomisation allocation software 2.0. The generated codes were sealed in sequentially numbered opaque envelopes. Informed consent was taken from all the participants of the study. The participants were recruited using the following inclusion and exclusion criteria:
Inclusion criteria
1. All patients requiring microvascular anastomosis.
2. Patients willing to consent for the study.
Exclusion criteria
1. Presence of active infection.
2. Patients unfit for surgery.
3. Patients requiring end to side anastomosis.
Data Collection:
1. Assessment of patency of anastomosis by direct examination of the flap to evaluate the success rate.
2. Calculation of clamping time from clamping to de-clamping the vessel.
3. Calculation of anastomosis time from grasping the needle with the needle holder to cutting of the last suture.
4. Assessment of the need for clamp flipping.
5. Assessment of need of assistance using Shira clamp compared to Acland clamp.
6. Evaluation of ease of use.