To investigate whether application of Steri-Strip* S will lead to: 1) shorter treating time 2) improved satisfaction with the patient 3) improved wound healing4) improved cost-efficiency5) improved satisfaction with the attendant
ID
Source
Brief title
Condition
- Procedural related injuries and complications NEC
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Mean difference in treatment time
• Mean difference in satisfaction score in patients
• Mean difference in pain score
• Incidence of adverse events e.g. wound infection
• Mean difference satisfaction score of wound healing in experts
(cardiothoracic surgeon and dermatologist)
Secondary outcome
• Mean difference in costs-efficiency
• Mean difference in satisfaction score in attendants
• Use of pain medication after surgery
Background summary
During bypass surgery (CABG) usually a incision is made in thorax and a vein is
harvested from the lower limb to use as a graft. The vein is surgically
removed, thereby inflicting a wound in the lower limb from the ankle to the
knee. These wounds are traditionally closed in two layers; one running
subcutaneous suture and the skin is closed with a running intercutaneous
suture. Disadvantages of using a intercutaneous suture for closing of the skin
are; (1) inflicting of micro traumata of the skin, by use of a needle, (2)
intervariability between surgeons, (3) strangulation of the skin through a too
tightly suture or dehiscence of the skin when a suture is too loose, (4) it is
time consuming and (5) there are risk of needle stick injuries.
Now a days there alternative methods of closing the skin were these
disadvantages are not present. These methods use adhesive strips which are
placed on either side of wound-edges and subsequently are pulled together,
after which they are fixated. These adhesive strips are commercially available
with the firm 3M and called *Steri-Strip* S*.
Both methods are commonly used in the cardiothoracic surgery and general
surgery. However both methods are never been compared to each other.
Study objective
To investigate whether application of Steri-Strip* S will lead to:
1) shorter treating time
2) improved satisfaction with the patient
3) improved wound healing
4) improved cost-efficiency
5) improved satisfaction with the attendant
Study design
A open, prospective, randomized mono-center study.
Intervention
Patients who are participating in this study are randomized in two groups. In
both groups The wounds wil be closed with a running subcutanous suture. In
one group the skin wil be closed with a monocryl running suture. In the other
group the wound wil be closed using Steri-Strip* S. These strips are placed on
either side of wound-edges and subsequently are pulled together, after which
they are fixated. This causes the wound-edges to lay side by side. The strips
wil remain attached to the patient for 14 days, after which they are removed.
Study burden and risks
Theoretically there is risk of adverse effect of the skin e.g. rash and
dehiscence of the adhesive strip. Never the less these adverse effect are never
been reported even though the Steri-Strip* S is widely used. Moreover is the
Steri-Strip* S latex free.
possible benefits; Reduction of treating time, reduction of risk for surgical
wound infection, improved wound healing, reduced pain sensation at surgical
sites and lower costs.
Michelangelolaan 2
5623 EJ Eindhoven
Nederland
Michelangelolaan 2
5623 EJ Eindhoven
Nederland
Listed location countries
Age
Inclusion criteria
patient undergoing coronary artery bypass surgery with patent superficial saphenous vein
Exclusion criteria
no
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 | NL20596.060.07 |