UMIN-ICDS Clinical Trial

Public title

Does applying a dressing to a wound after a cesarean section help it heal nicely?

Acronym

PEHDPoCS study

Scientific Title

Preventive Effect of Hydrocolloid Dressings on Hypertrophic Scarring of Post-Cesarean Section Wounds -A Randomized Pilot Study.

Scientific Title:Acronym

PEDYS study

Region

Japan

Condition

Hypertrophic scar after cesarean section

Classification by specialty

Obstetrics and Gynecology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Wound thickening is not uncommon after surgery. In post-Cesarean section, patients are particularly aware of the problem because they are female and relatively young. On the other hand, there is still a lack of evidence regarding the preventive effect of dressings on postoperative wound thickening scarring. This is due to the difficulty of long-term follow-up and assessment of hypertrophic scarring. Recently, however, more accurate and reproducible evaluation methods have been developed. Using these new evaluation methods, we aimed to clarify the efficacy of hydrocolloid dressings in preventing hypertrophic scarring in postoperative Cesarean wounds.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Hypertrophic scarring score at 12 months after cesarean section

Key secondary outcomes

Hypertrophic scarring score at 6 months after cesarean section
Risk ratio of hypertrophic scarring with intervention
Risk factors for hypertrophic scarring

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Interventions: Hydrocolloid dressings are applied to the wound 5-7 days after cesarean section and are changed every week for 6 months.

Interventions/Control_2

Control: Nothing is applied to the wound.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

Patients who had a cesarean section performed at our hospital between June 1 and December 31, 2019

Key exclusion criteria

Patients who are unable to give consent to participate in this study
Patients who cannot understand the description of our study due to language problems
Patients who have difficulty coming to our hospital in the 12th month after cesarean section due to geographical or other reasons
Patients with strong skin allergies
Patients with sever sugical site infection
Patients taking immunosuppressive drugs or steroids

Target sample size

62

Name of lead principal investigator

1st name	Hiroaki
Middle name
Last name	Tsubouchi

Organization

Rinku General Medical Centre

Division name

Department of Obstetrics and Gynecology

Zip code

598-0048

Address

2-23, Rinku Ourai-Kita, Izumisano, Osaka, Japan

TEL

072-469-3111

Email

h-tsubouchi@rgmc.izumisano.osaka.jp

Name of contact person

1st name	Hiroaki
Middle name
Last name	Tsubouchi

Organization

Rinku General Medical Center

Division name

Department of Obstetrics and Gynecology

Zip code

598-0048

Address

Rinku Ourai Kita 2-23, Izumisanoshi, Osaka, Japan

TEL

072-469-3111

Homepage URL

Email

h-tsubouchi@rgmc.izumisano.osaka.jp

Institute

Rinku General Medical Center

Institute

Department

Personal name

Hiroaki Tsubouchi

Organization

ALCARE Co., Ltd.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Rinku General Medical Center Institutional Review Board

Address

Rinku Ourai Kita 2-23, Izumisanoshi, Osaka, Japan

Tel

072-469-3111

Email

j-chiken@rgmc.izumisano.osaka.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

りんくう総合医療センター（大阪府）

Date of disclosure of the study information

2023

Year

02

Month

01

Day

URL releasing protocol

https://search.jamas.or.jp/search/do/detail/sidx/0/sid/2

Publication of results

Published

URL related to results and publications

https://search.jamas.or.jp/search/do/detail/sidx/0/sid/2

Number of participants that the trial has enrolled

135

Results

. Statistical analysis showed that each evaluation methods resulted in lower scores significantly at 6 and 12 months after cesarian section. Hypertrophic scarring (JSS:6-15) was present in 14/47 (29.8%) of the total patients, with a risk ratio of 0.623 (95% CI:0.417-0.930) for the intervention. The risk factor for hypertrophic scarring was midline vertical incision, with an odds ratio of 20.5 (95% CI:4.18-100.92).

Results date posted

2023

Year

01

Month

17

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Overall:age 32.7+-4.5, tall 158+-5.3cm, number of weeks of pregnancy 33(38-41)weeks, pre-pregnant body weight 56.0(380193)kg, pre-pregnant BMI 22.2(16.9-38.8), body weight at C/S 65.9(49.1-112)kg, BMI at C/S 26.2(20.4-42.2), abdominal cermumfarence at C/S 99(80-127)cm, abdominal wall thickness 1.3(0.1-21.7)cm.
Control group: age 31.7+-3.9, tall 158+-5.7cm, pre-pregnant body weight 56.0(41.0-103)kg, pre-pregnant BMI 22.4(17.1-38.8), body weight at C/S 65.6(49.1-112)kg, BMI at C/S 20.4-42.2), abdominal cermumfarence at C/S 100.6+-10.3cm, abdominal wall thickness 1.0(0.6-3.7)cm, abdominal wall thickness>2cm 2(8.3%), smoker 4(16.7%), HDP 1(4.2%), GDM 2(8.3%), 2 or more multipara 11(45.9%), emergent C/S 13(54.2%), prior lower abdominal surgery 10(37.5%), scar length 10(4.5-16)cm, postpartum endometritis 2(8.3%), superfisial SSI 1(4.2%), suture protruding 6(25%), EDPS at 1 month after C/S 3.96+-3.54.
Intervetion group: age 33.9+-4.9, tall 158+-4.9cm, pre-pregnant body weight 55.0(38.0-86.0)kg, pre-pregnant BMI 22.2(16.9-31.2), body weight at C/S 66.7(50.6-95.3)kg, BMI at C/S 26.2(21.5-35.7), abdominal cermumference at C/S 100.3+-7.9cm, abdominal thickness 1.1(0.5-3.5)cm, abdominal thickness>2cm 3(13%), smoker 0, HDP 6(26.1%), GDM 4(17.4%), 2 or more multipara 10(45.3%), emergnent C/S 11(47.8%), midline vertical incision 7(30.4%), prior lower abdominal surgery 14(60.9%), scar length 12(7.0-18)cm, postmartum endometritis 5(21.7%), superficial SSI 13(13.0%), suture proturuding 6(25%), EDPS at 1 month after C/S 3.26+-2.82.

Participant flow

The number of patients who had a cesarean section at the hospital during the period was 135, of which 33 were excluded due to strong allergies or difficulty in attending the hospital, 40 patients did not consent to the study, and the remaining 62 who consented were randomly assigned. The control group consisted of 24 of 31 patients.

Adverse events

itchy skin
rash
sore

Outcome measures

JSS classification(6M): control 5(2-12), intervention 3(2-10)
JSS classification(12M): control 5(1-12), intervention 3(1-10)
JSS evaluation(6M): control 5(0-11), intervention 2(0-7)
JSS evaluation(12M): control 4(0-10), intervention 0(0-8)
POSAS observer scale(6M): control 30(8-50), intervention 15(7-37)
POSAS observer scale(12M): control 25(6-45), intervention 8(6-41)
POSAS patient scale(6M): control 27(6-46), intervetion 15(6-45)
POSAS patient scale(12M): control 24(6-46), intervention 11(8-39)

hypetrophic scar(JSS classification 6-15) 6M: control11/24(45.8%), intervention 2/23(8.7%), relative risk 0.593(95%CI;0.402-0.575)
hypetrophic scar(JSS classification 6-15) 12M: control11/24(45.8%), intervention 2/23(13.0%), relative risk 0.623(95%CI;0.417-0.930)

In all cases, 33/47 had matured scars, 14/47 had hypertrophic scars, and none had keloids.
Matured scars(n=33): age 33+-4.7years, tall 158+-4.9cm, pre-pregnancy body weight 56.0(38.0-80.0)kg, pre-pregnancy BMI 22.2(18.8-28.8), body weight at C/S 66.7(49.1-89.0)kg, BMI at C/S 27.3+-3.8, abdominal wall thickness 1.1(0.1-3.5)cm, incision length 11.7+-2.45cm, EDPS 3(0-11), midline vertical incison 5(15.2%), prior lower abdominal incision surgery 18(54.5%), evergency C/S 17(51.5%), GDM 4(12.1%), HDP 6(18.2%), superficial SSI 4(12.1%), postpartum endometritis 6(18.2%), suture protruding 8(24.2%), smoker 1(3.0%).
The only factor that was significantly more common in patients with hypertrophic scars was the midline vertical incision, with a risk ratio of 20.533(95%CI;4.178-100.915).

Plan to share IPD

the data sets used and analyzed during the current study are available from the corresponding author upon reasonable reauests.

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2019

Year

04

Month

01

Day

Date of IRB

2019

Year

04

Month

15

Day

Anticipated trial start date

2019

Year

06

Month

01

Day

Last follow-up date

2021

Year

04

Month

05

Day

Date of closure to data entry

2021

Year

04

Month

15

Day

Date trial data considered complete

2021

Year

04

Month

20

Day

Date analysis concluded

2022

Year

04

Month

05

Day

Other related information

Registered date

2023

Year

01

Month

30

Day

Last modified on

2023

Year

01

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057005