Plain English Summary
Background and study aims
The death of tissue as a result of deficient blood supply (ischaemic gangrene) is treated by amputation of the affected body part. This results in a large number of wound complications and death. There are two methods of amputation in common use, one-stage and two-stage.
Two-stage amputation is a well-known way to reduce wound complications in patients with a high risk of infection (e.g. contaminated trauma or infected diabetic foot), but there is still lack of evidence if it can lower the mortality in severely ill patients with a complicated background of diseases.
Who can participate?
Patients requiring urgent amputation.
What does the study involve?
Records were collected for patients who had either had amputation using intensive treatment during 24 - 72 hours before surgery, and then fulfil one-stage amputation, or immediate guillotine amputation followed by reampuation after stabilisation.
What are the possible benefits and risks of participating?
None (retrospective study)
Where is the study run from?
Vinogradov Moscow Municipal hospital (Russia)
When is the study starting and how long is it expected to run for?
December 2017 to December 2018
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Vitaly Tsvetkov, tsvetkow@yandex.ru
Trial website
Contact information
Type
Scientific
Primary contact
Prof Vitaly Tsvetkov
ORCID ID
http://orcid.org/0000-0002-2889-702X
Contact details
61
Vavilova str.
Moscow
117292
Russian Federation
+7 9166312613
tsvetkow@yandex.ru
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Two-phase versus one-stage amputation of lower limbs among critically ill patients with ischemic gangrene as a way to reduce lethality and improve treatment outcome. Retrospective cohort trial.
Acronym
TPACIP
Study hypothesis
Use of urgent guillotine amputation of lower limb in critically ill patients with ischaemic gangrene as the first stage of surgical treatment allows to reduce lethality, number of wound complications and improve functional result.
Ethics approval
Approved 24/02/2018, Local Ethics Committee of the V.V. Vinogradov Moscow Municipal Hospital (61, Vavilova str., Moscow, Russia; no telephone number provided; ezhovalg@mail.ru), ref: none provided
Study design
Observational cohort retrospective study in two clinical centers
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
n/a (retrospective review of patient records)
Condition
Ischaemic gangrene of lower limb
Intervention
Retrospective comparison of two approaches to the treatment of critically ill patients who admit to the hospital due to ischaemic gangrene of lower limb.
In 2011- 2014 (control group) the tactic was to perform intensive treatment during 24 - 72 hours before surgery, and then fulfil one-stage amputation with primary formation of the stump.
In 2014 - 2018 (main group) the patients underwent urgent guillotine amputation or knee disarticulation, and then, after normalisation or stabilisation of general condition, reamputation with formation of the stump was performed.
The goal of the study is to compare these surgical tactics and their influence at the lethality, number of wound complications and functional
Records are gathered for patients in two groups:
1. Two-phase amputation including urgent guillotine amputation or knee disarticulation as a first stage an then reamputation with shaping of stump after stabilisation of patient general condition.
2. Intensive treatment before surgery, then one-stage amputation.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Lethality of procedure measured using patient records at a single time point
Secondary outcome measures
Measured using patient records at a single time point:
1. Number of wound complications
2. Levels of amputation
Overall trial start date
20/12/2017
Overall trial end date
29/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Need to perform urgent (within 72 hours after admission to the hospital) high amputation of the lower extremities in patients with critical limb ischemia who were admitted in a severe or extremely severe condition. The indication for amputation was gangrene accompanied by a progressive infection of soft tissues or a syndrome of endogenous intoxication caused by ischemic damage to the muscle tissue of the limb.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. Patients with surgical soft tissue infection but without occlusion of the main arteries (including patients with extensive limb phlegmons with a neuropathic form of diabetic foot syndrome)
2. Patients with planned indications for amputation (including those operated within 72 hours after admission), e.g., patients with critical ischemia and gangrene of the limb if angiosurgical intervention is impossible or unsuccessful
3. Patients in whom the indications for urgent amputation of the limbs occurred during their stay in the hospital
Recruitment start date
01/01/2011
Recruitment end date
31/12/2018
Locations
Countries of recruitment
Russian Federation
Trial participating centre
Vinogradov Moscow Municipal hospital
61, Vavilova str.
Moscow
117292
Russian Federation
Trial participating centre
Moscow Municipal Clinical hospital 53
26, Trophimova str
Moscow
115432
Russian Federation
Sponsor information
Organisation
Sechenov University
Sponsor details
8
Trubetskaya str.
Moscow
119048
Russian Federation
+7 (495) 609-14-00
rektorat@sechenov.ru
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication in peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request after the results have been published.
Intention to publish date
01/09/2020
Participant level data
Available on request
Basic results (scientific)
Publication list