Protocol summary

Summary
The aim of this study was to investigate the influence of platelet- rich plasma (PRP) Gel therapy on wound healing in patients with pilonidal sinus after surgery. One hundred twenty three patients who had surgery for pilonidal sinus were enrolled in this single center phase III clinical trial. All patients were treated by wide excision and open secondary intention. Exclusion criteria were as follows: lower platelet count of <1000/µL, hemoglobin <10 mg/dl, anti-proliferative therapies such as chemotherapy and also radiation in past 3 months, anti-inflammation medications in past 2 weeks, growth factor therapies in last 2 weeks, history of diabetes, history of mal-absorption (celiac disease) and any contra-indication in peripheral venues access. After assessment of eligibility criteria, patients were randomized into control and PRP treatment groups using block method. In PRP group, the obtained PRP was additionally injected into the depth (13mm) of the wound. It was also applied to center of each circle (0.1cc) and wound site (1 cm in diameter) through injection. PRP Gel was then added to the 2ml/cm3 of wound volume and the casual dressing was performed. Classical dressing (sterile absorbent cotton gauze) was applied for the control group. In both groups, the wounds were washed by normal saline (0.9%) twice a day. Wound debridement was also performed to remove the necrotic tissues if necessary. Quality of life and healing duration were evaluated in both groups up to the end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016020418842N11
Registration date: 2016-03-16, 1394/12/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-03-16, 1394/12/26
Registrant information
Name
Leyla Sharifi Aliabadi
Name of organization / entity
Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 3691
Email address
ctu@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study on potential of platelet-rich plasma Gel and regular dressing in duration of wound healing in patients who underwent pilonidal sinus surgery
Public title
The effectiveness of PRP Gel in wound healing caused by resection of Pilonidal sinus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Any patient diagnosed with pilonidal sinus disease with a scheduled surgery. Exclusion criteria: lower platelet count of <103/µL; hemoglobin <10 mg/dl; anti-proliferative therapies such as chemotherapy and also radiation in past 3 months; anti-inflammation medications in past 2 weeks; growth factor therapies in last 2 weeks, history of diabetes, history of mal-absorption (celiac disease); any contra-indication in peripheral venues access ; not willing to participate in the study.
Age
From 18 years old to 47 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 123
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hematology, Oncology and Stem Cell Transplantation Research Center, Tehran Unive
Street address
Shariat Hospital, North Kargar St.
City
Tehran
Postal code
1411713135
Approval date
2015-12-24, 1394/10/03
Ethics committee reference number
ir.tums.horcsct.rec.1394.103.4

Health conditions studied

1

Description of health condition studied
Pilonidal Sinus Disease with abscess
ICD-10 code
L05.02
ICD-10 code description
Pilonidal sinus with abscess

Primary outcomes

1

Description
wound healing time
Timepoint
Weekly up to full healing
Method of measurement
Wound volume measurement by filling the wound with saline. The volume dispensed from the syringe equals the wound volume.

2

Description
Quality of life
Timepoint
Weekly after start treatment up to average 8 weeks
Method of measurement
Quality of life questionnaire SF12 and 26

Secondary outcomes

1

Description
Angiogenesis
Timepoint
In PRP group: between 4-6 weeks In control group: between 8-10 weeks
Method of measurement
Immuno Histochemistery (IHC) on biopsy sample

Intervention groups

1

Description
In intervention group,the obtained PRP was additionally injected into the depth (13mm) of the wound. It was also applied to center of each circle (0.1cc) and wound site (1 cm in diameter) through injection. The injection was preformed right after surgery and then weekly. Then the PRP Gel (activated by CaCl2) was added 2ml/cm3 of wound volume and the casual dressing performed. Washing the wound with normal saline (0.9%) twice a day was ordered. Wound debridement was also performed to remove the necrotic tissues if necessary.
Category
Treatment - Drugs

2

Description
Classical dressing (sterile absorbent cotton gauze) was applied for the control group. Washing the wound with normal saline (0.9%) twice a day was ordered. Wound debridement was also done in order to remove the necrotic tissues whenever necessary.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of general surgery of Shariati Hospital, Tehran University of Medical Sciences.
Full name of responsible person
Shirzad Nasiri
Street address
Clinic of general surgery, Shariati Hospital, North Kargar St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences.
Full name of responsible person
Dr Masoud Younesian
Street address
Shariati Hospital, North Kargar St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Tehran University of Medical Sciences.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hematology, Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci
Full name of responsible person
Kamran Alimoghadam
Position
Subspecialty of Hematology and Oncology
Other areas of specialty/work
Street address
Hematology, Oncology and Stem Cell Transplantation Research Center, Shariati Hospital, North Kargar St.
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2635
Fax
Email
alimgh@sina.tums.ac.ir
Web page address
http://horcsct.tums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hematology, Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci
Full name of responsible person
Saeed Mohammadi
Position
PhD
Other areas of specialty/work
Street address
Hematology, Oncology and Stem Cell Transplantation Research Center, Shariati Hospital, North Kargar St.
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
saeedm_58@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hematology, Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci
Full name of responsible person
Leyla Sharifi Aliabadi
Position
BSc
Other areas of specialty/work
Street address
Hematology, Oncology and Stem Cell Transplantation Research Center, Shariati Hospital, North Kargar st.
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2669
Fax
+98 21 8800 4140
Email
ctu@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...