Condition category
Circulatory System
Date applied
06/07/2020
Date assigned
07/07/2020
Last edited
07/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

https://sechenov.ru/eng/

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

Publication citations

Additional files

Editorial Notes

07/07/2020: Trial’s existence confirmed by Local Ethics Committee of the V.V. Vinogradov Moscow Municipal Hospital.