DERMAL TEMPLATE USE FOR COMPLEX SOFT TISSUE DEFECTS- AN OBSERVATIONAL STUDY
- Conditions
- Health Condition 1: L989- Disorder of the skin and subcutaneous tissue, unspecified
- Registration Number
- CTRI/2024/04/065325
- Lead Sponsor
- Kasturba medical college
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
All patients with complex defects, of any age group scheduled for plastic reconstruction.
Patient willing to follow protocol and giving positive consent.
ii. Patient profile includes:
a. Complex wounds which are non-graftable following serial dressings and thorough
surgical debridement.
b. Patients in whom multiple procedures were already done for trauma or where the
potential recipient vessels come within the trauma zone and not feasible for free
flap.
c. Patients in whom flap failure has occurred and simple methods of local tissue
transfer are not feasible.
d. Non infective wounds confirmed by gram staining and negative culture.
e. Areas where chances of post-operative scarring and /or contractures are greater,
owing to location, nature and etiology of injury.
Exclusion criteriai. Patients whose defect does not fit the criteria for dermal template
ii. Patients not giving positive consent or not following protocol
iii. Patients who are lost for follow up and who developed systemic infections will be
secondarily excluded.
iv. Deranged liver, kidney, lung, cardiac functions
v. Patients in whom waiting for 3 weeks before grafting is not feasible in case of IDRT®and
waiting for a minimum of 5 days not feasible in case of Matriderm® .
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of wound healing by area of defect covered after dermal template <br/ ><br>reconstruction.Timepoint: 1 year <br/ ><br>
- Secondary Outcome Measures
Name Time Method Proportion of patients with IDRT failure. <br/ ><br>ii. Proportion of patients needing other tissue transfer like flap in case of DRT failure <br/ ><br>iii. Proportion of patients with immediate postoperative complications. <br/ ><br>iv. Mean POSA score of patients at follow up. <br/ ><br>v. Proportion of patients with poor functional outcomes and delayed postoperative <br/ ><br>complications. <br/ ><br>vi. Comparison of reconstruction outcomes of dermal template with flap reconstructionTimepoint: 1 year