Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04613336 |
| Other study ID # |
dow123 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 30, 2020 |
| Est. completion date |
February 2021 |
Study information
| Verified date |
November 2020 |
| Source |
Dow University of Health Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Wound is defined by the breach in dermis of the skin. It can be caused by road traffic
accidents, tumor excision, chronic illness like diabetes, bed sores in bedridden patients,
burns, insects' bites etc. Treatment goals for wound coverage includes earliest debridement,
dressings, local antibiotics, limb elevation, fracture fixations and wound coverage. Skin
graft functions both as occlusive dressing, as a skin replacement and as a stimulus for
healing. Even though the usage of flaps to cover the wounds has been increased recently still
skin grafting serves as an easiest and simplest way of covering the wound. However, skin
grafting introduces another wound in addition to the existing wound, the donor site wound
(DSW). A secondary donor-site wound (DSW) is formed after harvesting split thickness skin
graft which adds up with the primary wound to increase the total size of the wounds for the
healing process. This donor site wound cause itching, pain and cosmetic embarrassment. That
is why the proper and timely healing of the donor site wound is of great importance. Basic
management of DSWs includes conventional dressings that provides absorption of bleeding
solely.
Description:
This is a randomized control trial that will be conducted at Dr. Ruth K.M. Pfau, Civil
Hospital Karachi for a duration of six months after approval of the synopsis. Randomization
will be done using sequentially numbered, opaque, sealed envelopes (SNOSE). A sample size of
total 60 patients was calculated through OpenEpi. Patients will be counseled about the
procedure of grafting and change of dressings postoperatively. Inclusion Criteria: age
between 18 to 55 years, both genders, non-hypertensive patients, hemoglobin levels more than
10 g/dl, Platelet count above 150 to 400 × 109/L, wounds for more than 6 weeks. Exclusion
Criteria: Hypertensive patients, bleeding tendencies (Disorder), immune-compromised, familial
history of bleeding. The trial will be registered with clinical trial unit (CTU) of the Dow
University of Health Sciences. Statistical analyses will be done using SPSS version 21.
Descriptive analyses will be reported for all variables including age, gender, treatment
group distribution and other independent and dependent variables. Inferential statistics will
be reported using comparison of treatment groups using repeated measure ANOVA. P-value of
<0.05 will be considered as significant. The expected total expenditure on the research
project will be twenty thousand.
Data will be collected with change of dressings at graft donor site wound (DSW) that is the
thigh. Study objectives will be discussed and explained to the patients before surgery as
part of their change of dressings post operatively as in routine. Potential benefits and
discomforts of the procedure will be explained. There is no potential adverse effects of
heparin on wound or patients. Participants will receive both oral and written information
about the study. Consent form will be filled by the participants. Questionnaire with
photographic assessment will be filled at every change of dressing.
Split-thickness skin graft will be harvested from medial side of thigh in two strips of about
10*6cm with a few cm break in between them, with a Humby knife adjusted on with a randomized
setting to harvest a fixed depth of skin graft. After harvesting the graft the donor site
wound will be photographed, cleaned with saline and dressed with impregnated wax gauzes and
sterilized cotton covered in roll gauze.
At first postoperative day, donor site cotton dressing will be opened. Heparin and
conventional dressing group allocation will be done through randomization in order to prevent
any confounding factors such as baseline differences in depth of wound. Patients will be
provided with paper chits to choose from, with A or B marked on it. The proximal strip of
donor site wound (DSW) will be dressed according to the chit chosen. Patients picking up A
chit will be dealt as 'control half (conventional dressing)', where by patients picking up B
chit will be dealt as 'intervention half'.
The 'control half' will be redressed with sterilized cotton covered in roll gauze whereas
'intervention half' of wound will be sprayed with 5000 I.U/ml concentration of the heparin
placed in a 5 cc syringe. Then the wound will be redressed with sterilized cotton covered in
roll gauze. This will be repeated on donor site 'intervention half' of wound on daily basis.
Skin graft donor site wound will be inspected by the faculty of Plastic surgery on the 7th
post-operative day and photographic assessment will be recorded.
The visual analogue scale (VAS) will be used to access pain
Wound healing will be assessed by following parameters; decrease in size of wound, reduction
of surrounding skin edema. Senior faculty will verify the assessment of wound healing.
Independent Variable Demographic variable: Age, Gender, Monthly household income Medical
History: Blood profile, Pain Intervention: 1.Conventional dressings 2. Heparin Spray
Dependent Variable: Healing Time
2.9 Statistical Analyses: Statistical Package for Social Sciences (SPSS version 21) will be
used for all statistical analyses.
Descriptive Statistics:
Descriptive statistics will be reported using mean and standard deviation for all continuous
variables and frequencies and percentages for all categorical variables.
Inferential Statistics:
Mean wound healing time (recorded in days) between two intervention groups will be compared
using Repeated measures ANOVA. p-value <0.05 will be considered as level of significance.
