We aimed to compare the results of split thickness skin grafts (STSG) and flaps in patients with chronic bilateral axillary hidradenitis suppurativa.
Design
The protocol of this study was approved by Vice-Chancellor for Research and Technology of Shahid Beheshti University of Medical Sciences, Tehran, Iran. All consents were obtained by surgical residents and attending physicians. The non-randomized clinical trial was consisted of 30 patients with bilateral axillary hidradenitis suppurativa who would undergone graft or flap surgery.
Settings and conduct
The study took place in Shohadaye Tajrish hospital. In this study blinding technique was not applicable.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18-70 years old, diagnosis of bilateral axillary hidradenitis suppurativa, American Society of Anesthesiology classes I and II, having informed consent to enter the study.
Intervention groups
The intervention group was 30 patients who were scheduled for first debridement. Wide excision of axillary hidradenitis was conducted. Then, a wet to dry depressing was applied.The patients were scheduled for their second operation to cover bilateral axillary wounds with split thickness skin grafts and flaps. An appropriate size STSG was harvested from anterior of right thigh in all patients to cover left axillary region. Right axillary wound was covered by fasciocutaneous flap taken from para-scapular region. The place of taking flap was repaired primarily. Dressings of the graft site were uncovered after five to six days and dressings of the flap sites were uncovered on the postoperative day one.
Main outcome variables
Complete recovery of the sides of graft and flap; recurrence; patients’ satisfaction; symmetry and cosmetics; return to work; pain on flap or graft site; pain on flap or graft region
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191019045155N2
Registration date:2020-01-23, 1398/11/03
Registration timing:retrospective
Last update:2020-01-23, 1398/11/03
Update count:0
Registration date
2020-01-23, 1398/11/03
Registrant information
Name
Negin Yavari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9600
Email address
negin.yavarii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2010-03-01, 1388/12/10
Expected recruitment end date
2015-04-01, 1394/01/12
Actual recruitment start date
2010-03-21, 1389/01/01
Actual recruitment end date
2015-03-20, 1393/12/29
Trial completion date
2015-03-20, 1393/12/29
Scientific title
Comparison of split thickness skin grafts and flaps in bilateral chronic axillary hidradenitis suppurativa: a prospective clinical trial
Public title
Tissue coverage in axillary hidradenitis suppurativa
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
َََAge between 18 and 70 years old
Diagnosis of bilateral axillary hidradenitis suppurativa
American Society of Anesthesiology classes of I and II
Having informed consent to enter the study
The patients were followed-up for one year and then were visited on a regular basis. At first one month after surgery then three, six and twelve months after their second operation.
Method of measurement
by visiting the patients and examining
2
Description
Recurrence
Timepoint
The patients were followed-up for one year and then were visited on a regular basis. At first one month after surgery then three, six and twelve months after their second operation.
Method of measurement
by visiting the patients and examining
3
Description
Patient's satisfaction
Timepoint
The patients were followed-up for one year and then were visited on a regular basis. At first one month after surgery then three, six and twelve months after their second operation.
Method of measurement
by visiting the patients and examining
4
Description
Range of motion of the shoulder
Timepoint
The patients were followed-up for one year and then were visited on on a regular basis. At first one month after surgery then three, six and twelve months after their second operation.
Method of measurement
by visiting the patients and examining
5
Description
Pain on side or region of the flap or graft
Timepoint
The patients were followed-up for one year and then were visited on a regular basis. At first one month after surgery then three, six and twelve months after their second operation.
Method of measurement
Universal Pain Assessment Tool (UPAT)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One group of 30 patients that received split thickness graft on left side and flap on right side after debridement of chronic bilateral axillary hidradenitis suppurative. The graft for the left side was harvested from anterior of right thigh and the flap was taken from para-scapular region. Dressings of the graft site were uncovered after five to six days and dressings of the flap sites were uncovered on the postoperative day one. The control and intervention groups were in the same person (left and right side).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-Tajrish hospital
Full name of responsible person
Abolfazl Afsharfard
Street address
Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Pr_shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Ziaei
Street address
Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abolfazl Afsharfard
Position
Professor of surgery
Latest degree
Subspecialist
Other areas of specialty/work
Vascular surgeon
Street address
Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abolfazl Afsharfard
Position
Professor of surgery
Latest degree
Subspecialist
Other areas of specialty/work
Vascular surgery
Street address
Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abolfazl Afsharfard
Position
Professor of surgery
Latest degree
Subspecialist
Other areas of specialty/work
Vascular surgery
Street address
Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the data will be available under the name of supplementary.
When the data will become available and for how long
All the data will be available after the publication of the article forever
To whom data/document is available
Data will be available to everybody upon request
Under which criteria data/document could be used
Data could be used by other researchers for meta-analysis and systematic review
From where data/document is obtainable
Data will be available as a supplementary file to the published article
What processes are involved for a request to access data/document