Condition category
Skin and Connective Tissue Diseases
Date applied
09/12/2019
Date assigned
20/12/2019
Last edited
20/12/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims:
Caesarean sections are increasingly used to deliver babies. In Poland about 40% of deliveries end in a C-section. Caesarean scar healing can require targeted actions to reduce tightness and pulling and separate it from surrounding tissues. Silicone patches have been shown to improve scar healing. This study aims to investigate whether manipulation of the skin and tissues around the scar, similar to massage, can improve healing still further.

Who can participate?
Women aged 18-45 after Caesarean section (within 6-12 weeks after the delivery)

What does the study involve?
Participants will be randomly allocated into one of two groups. Both groups will use silicone patches on the Caesarean scar. One group will also receive manual therapy treatment from a therapist once a week for 8 weeks and be shown how to repeat the treatment themselves at home. The scar and associated pain will be assessed before treatment, 1 month after treatment and 6 months after treatment.

What are the possible benefits and risks of participating?
Participants might benefit from learning more about their scar and how to encourage it to heal. They will all receive treatment that has been shown to improve scar healing. There are no side effects of the planned treatment.

Where is the study run from?
Opole Medical School (Poland)

When is the study starting and how long is it expected to run for?
October 2018 to April 2022

Who is funding the study?
Opole Medical School (Poland)

Who is the main contact?
Dr Lucyna Ptaszkowska, ptaszkowska.l@gmail.com

Trial website

http://wsm.opole.pl/3210/5723/projekty-badawcze.html

Contact information

Type

Scientific

Primary contact

Dr Lucyna Ptaszkowska

ORCID ID

http://orcid.org/0000-0002-7706-0971

Contact details

Opole Medical School
Katowicka 68
45-060 Opole
Opole
45-060
Poland
+48 695401515
ptaszkowska.l@gmail.com

Type

Public

Additional contact

Dr Malgorzata Pasternok

ORCID ID

http://orcid.org/0000-0002-5642-6436

Contact details

Opole Medical School
Katowicka 69
Opole
45-060
Poland
+48 506174008
pasmal@wp.pl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

KB/92/FI/2018

Study information

Scientific title

The effect of selected therapeutic (myofascial relaxation techniques and silicone patches) interventions on the biomechanical properties of scar tissue after Caesarean section

Acronym

Study hypothesis

1. Assessment of biomechanical properties of scar tissue within the scar after Caesarean section depending on the therapeutic intervention used (myofascial release techniques and silicone patches).
2. Assessment of improvements in Vancouver Scar Scale (VSS) and pain reduction (VAS).

Ethics approval

Approved 25/10/2018, Opole Medical School Bioethics Commission (Katowicka 68, 45-060 Opole, Poland; +48 774410882; sekprorek.ds.nauk@wsm.opole.pl), ref: KB/92/FI/2018

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet.

Condition

Scarring after Caesarean section

Intervention

Participants will be randomly assigned to one of two comparison groups. Randomization using a 1:1 randomization scheme will be carried out using computer-generated random numbers (simple randomization).

The therapy programme lasts 8 weeks during which all the participants receive the silicone patches to promote scar healing. In addition, women assigned to one of the groups will undergo manual therapy treatment consisting of 8 meetings with a qualified physiotherapist (once a week). They will also repeat the manual techniques themselves at home.

The manual scar therapy procedure based on myofascial relaxation techniques consists of techniques such as:
1. Overall stretching technique - 5 min
2. Technique of delicate circles - 5 min
3. Up and down stretching movements in the shape of the letter J - 5 min
4. Vertical lifting technique - 5 min
5. Skin rolling - 5 min
6. S-shaped technique - 5 min

All participants will undergo assessment of the biomechanical properties of the scar area before the start of treatment, 1 month after and 6 months after the therapy programme.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

1. Scar tissue tone assessed using the MyotonPRO digital palpation device before the start of the intervention, immediate after the end of the intervention and 1 month and 6 months after the end of the intervention
2. Scar tissue stiffness assessed using the MyotonPRO digital palpation device before the start of the intervention, immediate after the end of the intervention and 1 month and 6 months after the end of the intervention
3. Scar tissue elasticity assessed using the MyotonPRO digital palpation device before the start of the intervention, immediate after the end of the intervention and 1 month and 6 months after the end of the intervention

Secondary outcome measures

1. Scar severity (comprising vascularity, height/thickness, pliability, and pigmentation) assessed using the Vancouver Scar Scale before the start of the intervention, immediate after the end of the intervention and 1 month and 6 months after the end of the intervention
2. Scar pain assessed using a visual analogue scale (VAS) before the start of the intervention, immediate after the end of the intervention and 1 month and 6 months after the end of the intervention

Overall trial start date

01/10/2018

Overall trial end date

01/04/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women after Caesarean section within 6 weeks of surgery (transverse cut using the Pfannenstiel method)
2. Full healing of the wound after the scab falls off
3. Healthy on the day of the test
4. End of the puerperium period
5. Aged 18-45 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60

Participant exclusion criteria

1. Caesarean section was less than 6 weeks or more than 12 weeks previously
2. Incomplete wound healing (exudate, local inflammation)
3. Malaise on the day of the test
4. Caesarean section in multiple pregnancies
5. Lack of consent of the examined person

Recruitment start date

15/01/2020

Recruitment end date

30/09/2021

Locations

Countries of recruitment

Poland

Trial participating centre

Opole Medical School
Katowicka 68 Street
Opole
45-060
Poland

Sponsor information

Organisation

Opole Medical School

Sponsor details

Katowicka 68
Opole
45-060
Poland
+48 (0)774423546
snw@wsm.opole.pl

Sponsor type

University/education

Website

http://wsm.opole.pl/1/strona-glowna.html

Funders

Funder type

University/education

Funder name

Państwowa Medyczna Wyższa Szkoła Zawodowa w Opolu [Opole Medical School]

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned for publication in a high-impact 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.

Intention to publish date

30/12/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/12/2019: Trial's existence confirmed by Opole Medical School Bioethics Commission.