Comparison of Wound Healing for Diabetic Carbuncle Treated With Incision and Drainage Technique Using Cruciate Incision vs Saucerization Technique Both Followed by Vacuum Assisted Closure.
Phase: NA
Conditions: Carbuncle
Sponsor: King Edward Medical University

SYNOPSIS   
  
  
  
 
  
Submitted By:  
  
DR ADNAN ALI   
POST GRADUATE RESIDENT MS 
GENERAL SURGERY   
  
Supervisor:  
 DR SOMER MASOOD MALIK  
ASSOCIATE PROFESSOR OF SURGERY  
WEST SURGICAL WARD  
MAYO HOSPITAL LAHORE   
  
King Edward Medical University 
Lahore – Pakistan  
  
  
  

 
Title of Research Project:   
Comparison of wound healing for diabetic carbuncle treated with incision & drainage technique using 
cruciate incision versus saucerization technique both followed by vacuum assisted closure   
  
  
Synopsis Submitted For:  
  
        MD / MS / MDS            Ph. D  
        M. Phil                            
 Research Grant  
Discipline:  
  
Name Of The Applicant:  
   
D.O.B:   
  
Nationality:  
  
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Email:  
  
Qualifications (list all; with date of graduation):  
                   Qualification                                            Year                                                   Institution  
  
  
  
Practical Experience (list all; with dates of employment):  
  
  
  
  
  
KING EDWARD MEDICAL UNIVERSITY, LAHORE 

Name of Parent Institution (if on Deputation):  
 
 
Name of Academic Supervisor / Principal Investigator:  
  
  
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Name of Co Supervisor / Co-Principal Investigator  
  
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Convener, Institutional Review Board  
  
  
  
Signature:  
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Chairman (Advanced Studies & Research Board)  
  
  
                  
 Approved                               Not Approved  
  
  
  
  
  
  
  
                                               Vice Chancellor, KEMU  
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Date:   
  
  
  

  
TITLE:  
Comparison of wound healing for diabetic carbuncle treated with incision & drainage 
technique using cruciate incision versus saucerization technique both followed by vacuum 
assisted closure   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
   

  
  
  
INTRODUCTION:  
A carbuncle is an infective gangrene of skin and subcutaneous tissue, characterized by cluster 
of boils caused by bacterial infection, most commonly with Staphylococcus aureus. Carbuncle 
appears as tender painful lesion with cluster of severe boils filled with purulent Discharge. It 
mostly occurs at the nape of the neck, the back, shoulder or thighs1. Carbuncle is usually 
associated with immunocompromised patients specially in diabetics2,10. Treatment of 
carbuncle varies from conservative management to a radical surgery. It includes use of broad 
spectrum antibiotics, deroofing, incision & drainage and saucerization 1,3,4.  
Saucerization involves radical excision of all dead necrotic center and surrounding cellulitis. In 
saucerization healthy bleeding margins are achieved, whole septic focus is removed and 
patient may not need post-operatively antibiotics. This technique leaves the patient with 
significant intraoperative blood loss and large wound which may need blood transfusion and 
graft or flap coverage of the wound respectively 4,5.  
Incision & drainage is less radical procedure which gives a drainage pathway to underlying pus 
and broad spectrum antibiotics are given to control the remaining cellulitis and septic focus. 
This technique is associated with early healing and smaller scar. Patient’s postoperative stay 
in hospital is usually prolonged after incision & drainage till adequate control of sepsis  
3,4.   
Wounds and their management are fundamental to the practice of surgery. Vacuum assisted 
Closure provides a new paradigm for wound dressings. Vacuum-assisted wound closure (VAC) 
is a wound management technique that exposes wound bed to negative pressure by way of 
a Closed system.. The application of VAC therapy to a wound provides a moist wound-healing 
environment leading to enhanced granulation tissue formation and improved wound healing 
which is the standard of care for wound healing 6,8,9.  
The standard procedure of saucerization for diabetic carbuncle is associated with extensive 
Blood loss at the time of surgery due to wide excision. Blood loss often requires blood  
Transfusion. Additionally, the wound created needs to be filled by granulation tissue by  
Secondary intention/vacuum therapy which is translated into huge expenditure in terms of 
Dressings and financial loss due to days off work as well as larger scar mark. Whereas incision  
& drainage followed by vacuum assisted closure is and generally associated with decrease 
Blood, tissue loss and smaller scar mark. The study had been designed to compare the two 
procedures, saucerization versus Incision and drainage of a diabetic carbuncle followed be 
VAC with respect to wound healing.  
  
  
  

  
  
OBJECTIVES:   
To compare wound healing for diabetic carbuncle treated with incision & drainage technique 
using cruciate incision versus saucerization technique both followed by vacuum assisted 
closure in terms of blood loss , granulation tissue , duration required of wound healing and  
Post operative transfusion.   
  
 

OPERATIONAL DEFINITIONS:  
Blood Loss:   
Blood loss will be assessed by counting number of supersaturated gauze sponges measuring 
30x30cm used during surgery. 1 supersaturated sponge will be equal to 130ml of blood 7.  
Wound Healing:  
Wound healing will be assessed by using photographic wound assessment tool (PWAT). Score 
of PWAT ranges from 0-32, score less than 12 will represent wound is healing.  
Duration of Wound Healing:  
Duration of wound healing will be measured by calculating days between day of first surgery 
to the day when epithelial tissue appears on the wound.  
Blood Transfusion:   
Blood transfusion will be done for those patients having postoperative Hemoglobin levels less 
than 8mg/dl.   
  
  
 

HYPOTHESIS:   
There is a difference in wound healing for diabetic carbuncle treated with incision & drainage 
technique using cruciate incision versus saucerization technique both followed by vacuum 
assisted closure.  
MATERIALS AND METHOD:  
STUDY DESIGN:   
Randomized controlled trial.  
STUDY SETTING:   
This study will be conducted at surgical floor in Mayo Hospital Lahore.   
STUDY DURATION:  
6 months from the approval of synopsis.  
SAMPLE SIZE:  
Sample size of 124 patients (62 patients in each group) is estimated by using 10% absolute 
precision and 95% confidence level with expected percentage of wound healing In 
saucerization as 89% 3 and in incision and drainage as 6.6% 3.  
  
𝑍1−𝑎/2{𝑝1(1−𝑝1)+𝑝2(1−𝑝2)} 
        𝑁=
  
𝑑2 
  
  
Z1-α = confidence level 95% = 1.96  
P1 = population proportion 1= 2.34%  
P2 = population proportion 2 = 25%  d    
=   absolute precision 10%   
  
SAMPLING TECHNIQUE:   
Non probability convenient sampling   
  
 
  

SAMPLE SELECTION:   
Inclusion Criteria:   
All patients  of  either  gender  having  age 25-70 years with  ASA class 2-3 presenting to 
emergency department with carbuncle requiring surgical drainage.   
Exclusion Criteria:   
1. 
Failure to tolerate VAC   
2. 
Patient with co-morbidities like: CKD, CLD, CVA   
3. 
Patients not giving consent   
4. 
Close to the anal opening   
5. 
Wound near the joint   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  

DATA COLLECTION PROCEDURE:   
All the patients with diagnosis of carbuncle who fulfill the inclusion criteria will be admitted 
through emergency and outdoor department. Risk to benefit ratio will be explained to 
patients. After taking informed consent patients will be divided in two groups through lottery 
method. Group A will represent Incision and drainage group, while group B will represent 
saucerization group. Intraoperative blood loss will be estimated. Every patient will be 
admitted in ward and amoxicillin and Broad spectrum antibiotics will be given to patients. 
VAC dressing will be applied to every patient on 1st post op day, postoperatively patient’s 
Hemoglobin will be assessed for blood transfusion. Patients will be discharged once 
granulation tissue starts appearing on the wound . Patients will be called back for follow-up 
after every 14 days and will be assessed for wound healing using PWAT Score.  
STUDY TECHNIQUE:  
A 1.25cm thick foam film will be specially designed and sterilized. The system will be attached 
on the wound and a nelton catheter will be attached on the dressing. The whole area will be 
sealed using plastic fill sheet and sealed using tincture benzoic acid.   
The wounds will be declared healthy when they will be filled with healthy granulation tissue 
and had epithelial growth on their edges. The wound will be assessed by photographic wound 
assessment tool (PWAT). Photographic images included in the analysis were recorded by 
mobile Samsung galaxy S-9+ camera. Photographs will take in a variety of clinical settings in 
which lighting conditions will optimize to reduce glare and shadows and increase image 
contrast. Mobile will equip to adjust automatically to varying light to permit close-up images 
of the wound (3 to 6 feet away). Before photography, a 15-cm ruler with clear millimeter 
divisions will be placed next to the wound as well as a patient identification number and the 
date of the assessment. Care will be taken to ensure that the camera will angle perpendicular 
to the wound bed; however, the distance between the camera and the wound will vary in 
order to capture the entire wound, the ruler, patient identification number, date, and a 
sample of the surrounding skin. Photographs will take after having receive the patient’s 
written permission with the understanding that the patient’s identity would be concealed at 
all times.   
  
  
  
  
  
  
  
 
  

PWAT SCORING INSTRUCTIONS:  
Assess the wound photograph and rate each PWAT domain according to the response that 
best describes observed wound findings. When more than one characteristic is evident, rate 
according to the majority or predominate feature that is visible in the photograph.  Sub-scores 
are added together to obtain the total score. Total scores range from 0 to 32 where a 
decreasing total score indicates wound healing.  
 

 
  
  
  
  
  
 
  

DATA ANALYSIS PRODECURE:   
The data will be analyzed by SPSS v26.0. Mean and standard deviation will be used for 
Quantitative data and frequency and ratios will be used for qualitative data. Quantitative 
variables ( Blood loss, Duration of wound healing and PWAT score) will be assessed using t 
test. Qualitative variable ( blood transfusion) will be assessed using chi square test. P value 
less than 0.05 will be considered significant.  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

  
OUTCOME & UTILIZATION:   
If any of the technique proves better than the other then it will help the surgeons 
in training to follow that technique for better patient outcome in terms of early 
healing, no Transfusion and limited blood loss.  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
  
  
  
  

SCHEDULE/PHASING:  
  
 
Month  
 
 
  
  
1st month  
2nd and 3rd 
month  
4th month   
5th month  
6th month  
Review literature   
✓  
  
  
  
  
Data collection   
  
✓  
  
  
  
Data analysis   
  
  
✓  
  
  
Thesis writing   
  
  
  
✓  
  
Thesis submission   
  
  
  
  
      ✓  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

REFERENCES:  
1. Nishat M, Latif A, Chaudhry N, Ansar A, Choudry ZA, Butt MQ, et al. Management of 
Carbuncle; Prognosis of Surgical Treatment. Pak J Med.2018;12(2):637-9.  
2. Venkatesan R, Baskaran R, Asirvatham AR, Mahadevan S. ‘Carbuncle in diabetes’: a 
problem even today!. Case Reports.2017: doi: 10.1136/bcr-2017-220628. 
3. Bilal H, Bakhsh I, Lutfi IA, Gul S. Comparison of Deroofing and Cruciate Incision for 
Carbuncles. Pak J Med.2023;17(04):550.  
4. Hee TG, Jin BJ. The surgical treatment of carbuncles: a tale of two techniques. Iran. 
Red Crescent Med J. 2013 ;15(4):367.  
5. Kim YH, Kim H, Cheon JH, Kang DH. Epinephrine Infiltration and the Incidence of 
Bleeding Complications after Surgical Debridement of Pressure Ulcers with Negative 
Pressure Wound Therapy. J Wound Manag Res. 2019 ;15(2):85-90.  
6. Agarwal P, Kukrele R, Sharma D. Vacuum assisted closure (VAC)/negative pressure 
wound therapy (NPWT) for difficult wounds: A review. J.Ortho.trauma. 
2019;10(5):845-8.  
7. Algadiem EA, Aleisa AA, Alsubaie HI, Buhlaiqah NR, Algadeeb JB, Alsneini HA. Blood 
loss estimation using gauze visual analogue. Trauma monthly. 2016 ;21(2):197-9.  
8. Mallikarjunaswamy MB. Functional outcome of vacuum assisted closure (VAC) 
dressing therapy for the management of traumatic wounds and non-healing wounds. 
JCRD. 2024;15(02):195-8. 
9. Marangi GF, Mirra C, Gratteri M, Cogliandro A, Salzillo R, Segreto F, et al. Switching from 
Galenic to Advanced Dressings or Vacuum Assisted Closure Therapy Can Improve Quality of 
Life of Patients with Chronic Non-Responsive Pressure Skin Ulcers: Preliminary Data with 
Italian Translation of WOUND-Q. Adv. Wound Care. 2024 13(3):131-9. 
10. Sukumar, D., PV, S.M., Athulya, A. and Shaji, K., 2023. Ayurvedic Management of Diabetic 
Carbuncle-A Case Report. IJAYUSH.Case Reports, 7(4), pp.451-8. 
  
 
  
  
  
  
  
  
  
  

CRF PROFORMA 
  
COMPARISON OF WOUND HEALING FOR DIABETIC CARBUNCLE TREATED WITH INCISION &  
DRAINAGE TECHNIQUE USING CRUCIATE INCISION VERSUS SAUCERIZATION TECHNIQUE 
BOTH FOLLOWED BY VACUUM ASSISTED CLOSURE  
  
Sr. no.: _________________________________ Reg. No.: _____________________   
  
Name: _______________________________________________________________   
  
Address: _____________________________________________________________   
Groups: • Incision and drainage                                     •Saucerization Technique  
Age: ________ (years)  
Gender: •Male.                    •Female   
Blood loss : __________  
Transfusion : • No                 • Yes   
Wound healing score:  
  
Follow up  
  
At 2 week  
  
At 4 week  
  
At 6 week  
  
At 8 week  
  
At 10 week  
  
  
  
  
  
  
  

Sanctity of data - Affidavit  
I,Mr/Ms_________________________________________________S/o_______________________ 
__ Student  
of___________________________________________________________________________ 
working in _____________________________  
Under Supervisorship of __________________________________  
  
Hereby undertake to abide by the following rules  
1. That the data collected during my attachment at King Edward Medical University (to be 
call KEMU here after) for which authorization is being granted by the Institutional 
Review Board ( to be called IRB here after) of KEMU for which I have submitted my 
synopsis  
titled_______________________________________________________________________ 
_________________________________________________ shall be used exclusively for  
the purpose of “not for profit” research and will not use for any other purpose what so 
ever. Any financial gain or patent originating from this research shall be equally shared 
with KEMU.  
2. The data collected shall be strictly limited to the parameters defined in my synopsis titled  
___________________________________________________________________________ 
________________________________________________  
3. That the identity of patients (cases) shall not be revealed.  
4. That prior approval for research project (synopsis) has been obtained from the 
Institutional Review Board/ Ethical Committee of my parent institution.  
5. That appropriate recognition and acknowledgement shall be given to KEMU in the 
publication of the paper/papers or any other medium of communication what so ever, if 
it utilizes the data/ graphs/tables/pictures collected from the aforementioned research, 
furthermore, in any subsequent publication or any other medium of communication what 
so ever, if it utilizes the above mentioned data/graphs/tables/pictures with proper 
acknowledgement (as mentioned below) and with prior intimation and authorization of 
IRB of KEMU.  
6. The aforementioned acknowledgement/recognition shall be mutually decided between the 
principal investigator (myself) and the in charge of the unit concerned at KEMU, under 
intimation to the IRB of KEMU.  
I have read all the clauses of the above written agreement and hereby agree to be legally bound 
to this agreement in letter and spirit. I also understand that if I am in breach of this contract; I 
shall lose the right to the data/publication/graphs/tables collected/published (stored in any form 
physical/electronic) thereof. In addition, KEMU will reserve the right to initiate proceedings 
against me at any/all for a deemed appropriate. Research Supervisor (as shown below) shall stand 
witness and guarantor of this agreement and would be equally liable in case of breech of 
agreement.  
  
  
Signature (Principal Investigator)  
  
  
  
Signature of Supervisor NIC 
No.____________________  
  
  
  
NIC No.____________________  
  
  
Proforma for Evaluation of Research Synopsis  
Board of Studies   
NOTE:  (It should be filled in by All Members of BOS individually)  

Title:______________________________________________________________ 
__________________________________________________________________ 
__________________________________________________________________ 
_________  
  
A. Must fulfill all of the following.  
  
Sr.No.  Essential Criterion  
No  
Yes  
1.  
According to prescribed format  
  
   
2.  
Principal Investigator and Co investigator mentioned  
  
   
3.  
Consent form given  
  
   
4.  
Proforma for data collection given  
  
   
5.  
Follow up proforma given  
  
   
6.  
Non-compliance with previous research protocol  
   
  
7.  
Repitition of Study                                                                              
   
  
  
B. Kindly evaluate this research proposal and grade the research proposal 
against each item. Must get at least 1 in all sections to qualify. Please check 
the appropriate box.   
  
Sr. No.  Criterion  
Grading   
 
 
 
1.  
Novelty of research idea  
0  
1  
2  
3  
4  
5  
2.  
Potential for capacity building (Skills)  
0  
1  
2  
3  
4  
5  
3.  
Multidisciplinary  
0  
1  
2  
3  
4  
5  
4.  
Contribution of research topic 
towards public benefit  
0  
1  
2  
3  
4  
5  
5.  
Contribution of research topic 
towards medical knowledge  
0  
1  
2  
3  
4  
5  
  
  
  
Total Score  
25  
Score Obtain    
  
  
  
  
  
Name:____________________________ Signature: __________________________  
  
  
List of Required Documents For Approval of 
Institutional Review Board  
  

 Informed Consent Form in English and Urdu  
  
 Subject Recruitment Procedure  
(e.g OPD, Indoor, Advetisement)  
  
 Investigator’s Brochure and Available Safety  
Information for Patient  
(Please devise patient information in urdu detailing the complications, if any, and 
benefits of the device/ devices and comparison with conventional technique)  
  
 Investigator’s Curriculum Vitae detailing qualification  
  
 Sanctity of Data form - Affidavit duly filled in and signed  
  
 Detailed Visit Forms  
(Please make Seperate Proformas for every visit. Keeping in Mind Inclusion and 
Exclusion Criteria)  
 Minutes of Board Of Studies / Approval of BOS   
 Proforma for Evaluation of Research Synopsis filled in individually by 
members of the Board of Study  
 Soft Copy of Synopsis alongwith soft copy of articles of all 
references submit in Research Center on CD.