Prisma in minor amputations

Phase 4

Recruiting

• Conditions: minor amputation of the lower limb; Surgery - Other surgery

• Registration Number: ACTRN12619001174178
• Lead Sponsor: Dr Chris Delaney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-20
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

All patients undergoing minor amputation of the foot (single or multiple digits, to base of metatarsal as maximum depth debrided / amputated) at Flinders Medical Centre, where the surgical site has been left open to heal via secondary intention.

Exclusion Criteria

i.Patients who live interstate, rural or remote or who are not able to attend the scheduled appointed review time frames.
ii.Patients under 18 years of age.
iii.Patients who are unable to give informed consent due to language difficulties or physical/mental incapacity.
iv.A minor amputation where the operative wound bed has been closed using primary closure methods (suture, staples).
v.Patients with known hypersensitivity to any components of Promogran Prisma™ - oxidised regenerated cellulose, collagen and silver.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with 100% wound healing defined as: 100% wound bed epithelialisation prior to or by the end of the trial timeframe (12 weeks). [12 weeks]