Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04613336
Status:
UNKNOWN
Last Update Posted:
2020-11-03
First Post:
2020-10-16
Brief Title:
Efficacy of Topical Heparin Spray on Donor Site Wound Healing Time Compared to Conventional Dressing Among Patients Undergoing Split Thickness Skin Grafting
Sponsor:
Dow University of Health Sciences
Organization:
Dow University of Health Sciences
Study Overview
Official Title:
Efficacy of Topical Heparin Spray on Donor Site Wound Healing Time Compared to Conventional Dressing Among Patients Undergoing Split Thickness Skin Grafting
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
This is a randomized control trial that will be conducted at Dr Ruth KM 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 gdl Platelet count above 150 to 400 109L 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 005 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 106cm 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 IUml 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 1Conventional dressings 2 Heparin Spray
Dependent Variable Healing Time
29 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 005 will be considered as level of significance
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 106cm 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 IUml 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 1Conventional dressings 2 Heparin Spray
Dependent Variable Healing Time
29 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 005 will be considered as level of significance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None