| CTRI Number |
CTRI/2024/02/063148 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
02/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Wound Healing of Knotless Absorbable Suture and
Single Strand Absorbable Suture in Closure of Cut taken in Oral Cavity for fixing Facial Bone Fractures. |
|
Scientific Title of Study
|
Comparative Evaluation of Wound Healing of Knotless Barbed Absorbable Suture and Monofilament Absorbable Suture for Closure of Intraoral Incisions in Maxillofacial Trauma: A Prospective Randomized Controlled Clinical Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Sayali More |
| Designation |
1st Year Post Graduate Student |
| Affiliation |
MGM Dental College and Hospital,Kamothe |
| Address |
51,Varsha CHS,Sector-4,2nd Floor,Room No.10,Airoli,Navi Mumbai
MGM Dental College and Hospital,Junction of NH4 and Sion-Panvel Highway,Sector- 18,Navi Mumbai ,Maharashtra
Thane
MAHARASHTRA
400708
India |
| Phone |
9892102964 |
| Fax |
|
| Email |
drsayalimore97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sunil Sidana |
| Designation |
Professor |
| Affiliation |
MGM Dental College and Hospital,Kamothe |
| Address |
Department of Oral and Maxillofacial Surgery,4th Floor,MGM Dental College,Junction of NH4 and Sion-Panvel Hwy,Sector 18,Kamothe
Thane
MAHARASHTRA
410209
India |
| Phone |
9892102964 |
| Fax |
|
| Email |
drsunilsidana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sayali More |
| Designation |
1st Year Post Graduate Student |
| Affiliation |
MGM Dental College and Hospital,Kamothe |
| Address |
Department of Oral and Maxillofacial Surgery, 4th floor,MGM Dental College and Hospital,Kamothe ,Junction of NH4 and Sion - Panvel Hwy,Sector 18, Navi Mumbai
Thane
MAHARASHTRA
4102098
India |
| Phone |
9892102964 |
| Fax |
|
| Email |
drsayalimore97@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM DENTAL COLLEGE AND HOSPITAL,KAMOTHE,JUNCTION OF NH4 AND SION-PANVEL HWY,SECTOR 18,NAVI MUMBAI,MAHARASHTRA 410209 |
|
|
Primary Sponsor
|
| Name |
Dr Sayali More |
| Address |
MGM Dental College and Hospital,Kamothe,Junction of NH4 and Sion-Panvel Hwy,Sector 18,Navi Mumbai |
| Type of Sponsor |
Other [Self Funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SAYALI MORE |
MGM DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,4TH FLOOR
Raigarh
MAHARASHTRA |
9892102964
drsayalimore97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF MGM DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S024||Fracture of malar, maxillary and zygoma bones, (2) ICD-10 Condition: S026||Fracture of mandible, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Knotless Barbed Absorbable Suture |
Patients with Maxillofacial fracture comprising of Maxillary,Zygomaticomaxillary Complex or Mandibular fracture requiring intraoral incision for access to fracture site exposure and reduction will be selected for the study.Intraoral Incisions will be sutured and closed with Knotless Barbed Absorbable Suture and assessed for wound healing on further follow up. |
| Comparator Agent |
Monofilament Absorbable Suture |
Patients with Maxillofacial fracture comprising of Maxillary,Zygomaticomaxillary Complex or Mandibular fracture requiring intraoral incision for access to fracture site exposure and reduction will be selected for the study.Intraoral Incisions will be sutured and closed with Monofilament Absorbable Suture and assessed for wound healing on further follow up. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients indicated for intraoral incisions for access to fractures in cases with Le Fort 1 maxillary fractures,ZMC Fractures,Mandible fractures undergoing open reduction and internal fixation.
2.Age - 18 to 60 Years.
3.Patients willing to be a part off the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients with any pre-existing systemic disease or condition, history of medication with anti-coagulants, steroids.
2.Extraoral incisions
3.Contaminated wound
4.Patients diagnosed with oral submucosal fibrosis.
5.Preexisting scar from previous incisions or laceration
6. Patients not willing to be a part of the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound Healing in terms of Inflammation,Proliferation and Remodelling |
Inflammation will be assessed on Post-Operative Day 5,Proliferation will be assessed on Post- Operative Day 14 AND Remodelling will be assessed on Post-Operative Week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Variation in wound healing outcomes based on Age & Site of Incision |
At post operative day 5,post operative day 14 & post operative week 6 |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/03/2024 |
| Date of Study Completion (India) |
31/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Maxillofacial surgical practice frequently involves closure of wounds which may be traumatic or surgical incisions. Currently, the options for wound closure are numerous and range from suture materials (resorbable and non-resorbable) to non-suture materials such as cyanoacrylates, fibrin glue and adhesive tapes. Nevertheless, suturing remains the most commonly employed method of wound closure in intra-oral surgery whose objectives include the following; anatomic re-approximation of tissues, hemostasis and prevention of wound contamination through microleakage or entrapment of food. Further, for various surgical procedures, suturing must provide an ideal tissue-seal that prevents the underlying implants or grafts from getting infected. Numerous suture materials which vary in structure and composition are currently being used for intra-oral wound closure. These require placement of knots to secure the suture material to the tissues. However, intra-oral suturing presents the following clinical challenges related to knotting (1) Difficulty in placing the first tie and achieving the desired tissue approximation in areas of restricted access and instrumentation such as retromolar region and palate. (2) Propensity for knot slippage which compromises wound closure and necessitates a knot holding instrument or an assistant (3) Knot related tissue irritation, and (4) Knot being a nidus for food debris and microbial colonization. Knotless suture is a novel suture device which may be an ideal alternative to eliminate the above mentioned drawbacks. In addition, numerous knot related complications have been documented in literature such as accumulation of food debris leading to infection and soft tissue irritation and eventually wound dehiscence. Literature also reveals that knots over the wound can cause ischemia due to additional pressure which predisposes the wound to infection. Improper suturing leads to complications such as wound dehiscence, infection, and post-operative pain and hemostasis in the postoperative phase. Knotless suturing is an innovative method of wound closure used in the fields of bariatric surgery, abdominoplasty, facial rejuvenation procedures, laparoscopic myomectomy, partial nephrectomy, and in various minimally invasive procedures. The rationale of this study is to evaluate role of knotless barbed absorbable suture for intraoral wound closure in terms of wound healing compared to conventional monofilament absorbable suture. |