Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000115932
Ethics application status
Approved
Date submitted
22/10/2019
Date registered
7/02/2020
Date last updated
7/02/2020
Date data sharing statement initially provided
7/02/2020
Date results information initially provided
7/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changes in the structure of the caesarean scar as a result of therapy.
Scientific title
Differences in the structure of scar tissue after cesarean section in 30 women after surgery participating in and not participating in scar therapy.
Secondary ID [1] 299564 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Scar 314836 0
ceasarean section 314837 0
Condition category
Condition code
Physical Medicine / Rehabilitation 313174 313174 0 0
Physiotherapy
Reproductive Health and Childbirth 313175 313175 0 0
Childbirth and postnatal care
Skin 313720 313720 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The therapy consisted 4 week session of 30-minute each, carried out 3 times per week. 8 manual techniques were applied: stroking, superficial rubbing using spiral and transverse motions, deep running using spiral and transverse motions, moving, rolling, breaking-up, and pinching. All manual techniques were performed directly on the scar. Therapy was lead by Bsc of physiotherapy (Katarzyna Olszewska) under control PhD.PT of physiotherapy (Malgorzata Stefanska)
Intervention code [1] 315821 0
Rehabilitation
Intervention code [2] 316229 0
Treatment: Other
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 321706 0
Evaluation in tissue structure before and after manual therapy and comparative study between test group and control group. The scars were evaluated twice with the use of quantitative scales: the Vancouver Scar Scale (VSS), the Manchester Scar Scale (MSS), and the POSAS (Patient and Observer Scar Assessment Scale) Patient Scale.
Timepoint [1] 321706 0
5 weeks from enrolment
Secondary outcome [1] 375975 0
Nil
Timepoint [1] 375975 0
Nil

Eligibility
Key inclusion criteria
The criterion for inclusion in the treatment group were 3 - 36 month after caesarean section and the lack of any prior work on the scar.
Minimum age
20 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The criterion for exclusion in the treatment group was the prior work on the scar.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/01/2019
Date of last participant enrolment
Anticipated
Actual
12/04/2019
Date of last data collection
Anticipated
Actual
17/05/2019
Sample size
Target
40
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 21930 0
Poland
State/province [1] 21930 0
Lower Silesia (Wroclaw)

Funding & Sponsors
Funding source category [1] 304050 0
University
Name [1] 304050 0
University School of Physical Education
Country [1] 304050 0
Poland
Primary sponsor type
University
Name
University School of Physical Education
Address
al. Paderewskiego 35
51-612 Wroclaw
Country
Poland
Secondary sponsor category [1] 304243 0
None
Name [1] 304243 0
Address [1] 304243 0
Country [1] 304243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304541 0
University Ethics Committee
Ethics committee address [1] 304541 0
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw
Ethics committee country [1] 304541 0
Poland
Date submitted for ethics approval [1] 304541 0
Approval date [1] 304541 0
14/06/2018
Ethics approval number [1] 304541 0

Summary
Brief summary
The aim of the study was to evaluate the changes in the structure of the caesarean scar as a result of therapy. It was assumed that the therapy will improve the functional condition of the scar. 30 women (15 in the treatment group and 15 in the control group) participated in the study. The interval between the caesarean section and the study was 14 months on average. The scars were evaluated twice at a 5-week interval with the use of quantitative scales: the Vancouver Scar Scale (VSS), the Manchester Scar Scale (MSS), and the POSAS (Patient and Observer Scar Assessment Scale) Patient Scale. During each examination, the scar was compared – using the specified criteria – to the physiological skin, i.e. the tissues directly bordering the incision. The therapy consisted 4 week session of 30-minute each, carried out 3 times per week. 8 manual techniques were applied: stroking, superficial rubbing using spiral and transverse motions, deep running using spiral and transverse motions, moving, rolling, breaking-up, and pinching.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97322 0
Dr Malgorzta Stefanska
Address 97322 0
University School of Physical Education in Wroclaw
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw
room 2/33 building P4
Country 97322 0
Poland
Phone 97322 0
+48 71 347 30 46
Fax 97322 0
Email 97322 0
[email protected]
Contact person for public queries
Name 97323 0
Dr Agnieszka Ptak
Address 97323 0
University School of Physical Education in Wroclaw
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw
room 2/33 building P4
Country 97323 0
Poland
Phone 97323 0
+48 71 347 30 46
Fax 97323 0
Email 97323 0
[email protected]
Contact person for scientific queries
Name 97324 0
Dr Agnieszka Ptak
Address 97324 0
University School of Physical Education in Wroclaw
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw
room 2/33 building P4
Country 97324 0
Poland
Phone 97324 0
+48 71 347 30 46
Fax 97324 0
Email 97324 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 378566-(Uploaded-22-10-2019-19-07-01)-Basic results summary.docx

Documents added automatically
No additional documents have been identified.