The aim of this study is 1. to compare scarformation in two different operative protocols in a prospective manner of children who undergo sternotomy because of cardiologic disease. 2. to differentioate scar pain from sternotomy pain. 3. to estimate…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
POSAS score
Secondary outcome
- PedsQL score (quality of life)
- pain
- relation between POSAS score and age
- relation between PedsQL score and POSAS score / pain
Background summary
Pain after cardiac surgery in adults is very common. The reported incidence of
chronic post sternotomy pain (CPSP) varies from 21 to 56% according to various
studies. Although frequently reported the etiology has not yet been clarified.
By our knowledge this common pain syndrome has never been studied in children.
In the Netherlands, each year at least 1200 - 1600 children are born with
congenital heart malformations (source: www.rivm.nl). Most of these children
need surgical correction for their disease. Sternotomy itself is worldwide in
adults one of the most frequently performed operations. Sternotomy often leaves
unsighty and painful scars in both adults and children, although objective scar
assessment studies (like with POSAS) are very scarce. In the AMC/LUMC the
sternotomy wound is closed either by intracutaneous stiches or by Steri-strip
S. This last one has shown improved scar outcomes in sponsored studies. Quality
of life is thereby an important item because heart disease and sternotomy will
influence somebodies life in many ways. Unknown is whether age, postoperative
pain or scarformation have influence on the perception of quality of life for
the patient.
Study objective
The aim of this study is 1. to compare scarformation in two different operative
protocols in a prospective manner of children who undergo sternotomy because of
cardiologic disease. 2. to differentioate scar pain from sternotomy pain. 3. to
estimate quality of life of post sternotomy children.
Study design
A sample of 100 of children were recruited from the outpatient cardiothoracal
clinic at AMC and LUMC. Patients were identified by review of the clinic
schedule and medical charts. After informed consent and child assent was
obtained from the participating families, they were asked to complete
questionnaires at different stages:
- A= the PedsQL 4.0: quality of life
- B= the POSAS: scar assesment
- C= an additional pain and/or wound questionnaire
Before surgery (A,C); after surgery 4-6 weeks(C); 3 months (B,C); and 12 months
(A,B,C)
Filling in the questionnaires was done by:
Children Parents
< 5 years 5-7 years 8-11 years 12-18
years
PedsQL - + + + +
PainQ - + - + +
POSAS - - - + +
When the POSAS is obtained:
The investigator also fills in the POSAS questionnaire and assesses scar
sensitivity by striking a cotton wool swab over the scar and deep sternal pain
by giving pressure on the sternum and drawing the pain location on a body
scheme as well as taking a VAS score (smiley or numerical).
Intervention
Wound closure with steri-strip S or intracutaneous stiches by seeding.
N.B. Both wound closure methods are used at this moment dependent on the
surgeon.
Study burden and risks
- There is no expected risk connected to this study
- There is hardly any burden, as no invasive investigation is done, no extra
outpatient clinic visit.
- During the regular outpatient clinic visits, the patient is asked to fill in
a questionnaire and undergoes a scar assessment including VAS score/comfort
scale
meibergdreef 9
1105 AZ AMsterdam
NL
meibergdreef 9
1105 AZ AMsterdam
NL
Listed location countries
Age
Inclusion criteria
patients who undergo a primary sternotomy or a secondary sternotomy surgery in which the old scar is excised.
Exclusion criteria
patients who undergo an emergency surgery
patients who do not understand the dutch language
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL25569.018.09 |