There chain {5},{8}. Cyanoacrylate are synthetic surgical adhesive

There has always been a
concern among surgeons/ clinicians regarding the process of wound healing in
the oral mucosa after scalpel incision or surgical injury {1}. Wound closure is
the mainstay procedure in day to day practice of oral and Maxillofacial Surgery
{2}.`The ideal method of wound closure should be simple and easy , safe, quick,
cost effective, painless, ideally bactericidal , and produce optimal cosmetic results
{3}. The most common method of wound closure in oral surgery is suturing {4}.
suture have their own set of drawback which include trauma as result of cutting
needle, lodging microorganisms, susceptibility to infection, need for removal,
complications like stitch abscess, gaping of wound margins, necrosis of tissue
edges and risk of needle stick injury to the operating surgeon {5},{6}. Other
conventional methods of wound closure include staples and surgical tapes {7}.
Staples have been designed for external use and surgical tapes lose their
strength when come in contact with moisture so cannot be used for intraoral
wound closure {7}.

          Increase awareness and demand for aesthetic surgical
correction with quality in tissue closure has lead to the invention of new
materials and techniques {7}. Medical grade cyanoacrylate is one of them {7}.

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          cyanoacrylate was discovered in 1949 by German chemist. The
general formula is CNCH2=CO ON where R is the side chain {5},{8}. Cyanoacrylate
are synthetic surgical adhesive found to be effective in closure of low tension
lacerations. Its ease in application, immediate hemostasis, bacteriostatic
effect and rapid adhesion that save time are the main advantages. In many
studies, the efficacy of cyanoacrylate as a sclerosing agent in children’s
wound closure, craniofacial fixation, and so forth has been  supported by reports {9},{10}. In
Maxillofacial field it has been used for wound closure, skin graft, face lift,
blepharoplasty, brow lift and other cosmetic surgeries {10},{11},{12},{13},{14}.
Recently its usage in third molar surgery has been studied {2},{4}

          Very few studies have been conducted about its usage in
oral cavity {6}. In 2013, Kumar MS et al found that surgical incision closed
with cyanoacrylate heal with less inflammatory response as compared to sutures
{15}. Vastani et al found similar results in their study {1}. Setiya et al
observed that that the use of cyanoacrylate showed better hemostasis, decreased
pain and postoperative swelling as compared to the sutures {16}. Wound
dehiscence is the most common complication associated with the use of
cyanoacrylates,  reported as 1 – 10 % in
different studies {2},{6}

          Maxillofacial trauma is the most common surgical procedure
after third molar surgery. Mandibular trauma is most common among maxillofacial
trauma. Almost half of patients with maxillofacial injury have a fracture of
mandible. Parasymphysis site is the third most common site of fracture after
mandibular body and condyle {18}.

          The rationale of my study is to validate the effectiveness
of cyanoacrylate for closure of intraoral surgical incision as compared to  suture materials.

 

Hypothesis:

  Cyanoacrylate is better in closure of
parasymphysis region wound in terms of pain, swelling, bleeding,
infection/inflammation, wound healing and cosmosis.

 

Objective:

          To evaluate the efficacy of cyanoacrylate tissue adhesives
in the management of intraoral surgical wounds in terms of pain, swelling,
bleeding, infection, wound healing  and cosmosis
as compared to vicryl suturing.

 

Operational Definition:

 

Cyanoacrylate:

          It is a Synthetic tissue
adhesives that after polymerization form thin flexible film that held wound
margins together and act as a scab over which epithelial migration occur more
readily, as well as preventing secondary infection.

 

 

Efficacy:

          Efficacy of cyanoacrylate and vicryl suturing will be assessed
on the basis of pain, wound healing and Hollander Wound score  scale.

 

 

Pain:

 

          Pain is an unpleasant sensory experience perceived as
arising from specific location of the body and associated with actual and
potential tissue damage and it will be assessed by using visual analog scale.
(annexure 2).

 

Swelling:

 

           Swelling is a transient abnormal enlargement of a body
part or area not caused by proliferation of cells. It is caused by accumulation
of fluid in tissues. It can occur throughout the body (generalized), or a
specific part or organ can be affected (localized). It will be assessed by
using visual analog scale.

 

Bleeding:

 

          
The escape of blood from vessels or
surgical wound. It will be assessed by using visual analog scale.

 

Infection/Inflammation:

 

           Infection
– The following
clinical findings were defined as infections: prolonged alteration in wound
healing (i.e, wound dehiscence), formation of granulation tissue in the region
of the operation wound, local swelling and redness, or abscess formation.

           Inflammation
– a local response to cellular injury that is marked by capillary dilatation,
leukocyte infiltration, redness, heat, pain, swelling, and often loss of
function and that serves as a mechanism initiating the elimination of noxious
agents and of damaged tissue.

 

The diagnosis of SSI
(Surgical Site Infection) will be made on the Centre for Disease Control and
Prevention (CDC) criteria.  SSI is
divided into 3 main categories:

 

It will be assessed
according to the following scale :

 

 

 

 

 

 

 

 Grade

Signs

 

0

No sign of
infection

 

1

Simple stitch
abscess

 

2

Surrounding
cellulitis < 1cmm     3 Accompanying lymphangitis or lymphadenitis   4 Systemic Symptoms            Wound Healing                          The restoration of structure and function of injured or diseased tissues.  It will be assessed clinically according to following criteria on 1st , 2nd and 7th postoperative day.   Cosmesis: Cosmetic appearance of wound will be assessed by using Modified Hollander wound score scale.   Step-off of borders(edges not on the same plane)     Contour irregularities ( wrinkled skin near the wound)     Margin separation ( gap between the sides)     Edge inversion (wound not properly everted)     Excessive distortion (swelling or infection)     Patient satisfaction score (1-10)     Operator Satisfaction Score (1-10)         MATERIAL AND METHODS: Setting: Department of oral and maxillofacial surgery, Mayo Hospital, Lahore. Duration of Study: Minimum six months after the approval of synopsis. Study design: Randomized clinical trial Sample size: xx Sampling techniques: SAMPLE SELECTION: Inclusion criteria: ?   Patients of both gender ?   Age between 18 – 50 years. ?   Patient having mandibular parasymphysis fracture with no open wound. ?   Patients agree to participate in study and postoperative follow up schedule. Exclusion criteria: ?   Infected wound ?   Patient with any systemic disorders like diabetes mellitus, blood clotting disorders, peripheral vascular disease, collagen vascular disease etc. ?   Taking immunosuppressive drugs or on steroid therapy and bisphosphonate therapy ?   Any soft tissue or bony pathology causing gross deformity ?   History of keloid formation or a tendency to form hypertrophic scar ?   History of allergy to any drug especially formaldehyde. ?   Mental retarded patient. ?   Uncooperative and unwilling patient ?   Smokers       DATA COLLECTION PROCEDURE:   After the approval of synopsis, one hundred thirty six patients, fulfilling the inclusion criteria will be selected from the outdoor, indoor and emergency patient department of oral and maxillofacial surgery on the basis of history and clinical examination. After explaining the study protocol, use of data for research and risk-benefit ratio, informed consent will be taken from the patient. The patients' demographic details like name, age, gender etc. will be recorded on a structured proforma.  A single surgical team headed by a consultant will carry out the surgical procedure under general or local anesthesia. Strict aseptic measures will be taken.  Patients will be divided into two groups by using random number table into  group A and  group B. In group A, cynoacrylate will be used for closure of parasymphysis region wound after Open reduction and internal fixation of fracture. In Group B, vicryl suturing will be performed after ORIF of fracture. After achieving adequate hemostasis, closure will be performed with either tissue glue or vicryl suturing. Incision edges will be approximated accurately with an attempt not to leave any gap in between them. Flap will be isolated with dry gauze. Tissue glue will be applied on the incision line in form of drops at equidistant intervals in group A patients. Vicryl suturing will be performed in Group B patients. Pressure pack will be placed and postoperative instructions regarding diet, oral hygiene maintenance and medications ( analgesics and antibiotics) will be given to the patients or attendants. The researcher will evaluate pain, wound healing and wound cosmoses  wound  1st, 2nd and 7th  postoperative day and data will be recorded on the structured proforma.

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