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DERMAL TEMPLATE USE FOR COMPLEX SOFT TISSUE DEFECTS- AN OBSERVATIONAL STUDY

Usage Of Dermal Template for Reconstruction of Complex defects - a prospective observational study - IDRT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/065325
Enrollment
80
Registered
2024-04-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L989- Disorder of the skin and subcutaneous tissue, unspecified

Interventions

None listed

Sponsors

Kasturba medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 criteria

Exclusion criteria: 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® .

Design outcomes

Primary

MeasureTime frame
Rate of wound healing by area of defect covered after dermal template reconstruction.Timepoint: 1 year

Secondary

MeasureTime frame
Proportion of patients with IDRT failure. ii. Proportion of patients needing other tissue transfer like flap in case of DRT failure iii. Proportion of patients with immediate postoperative complications. iv. Mean POSA score of patients at follow up. v. Proportion of patients with poor functional outcomes and delayed postoperative complications. vi. Comparison of reconstruction outcomes of dermal template with flap reconstructionTimepoint: 1 year

Countries

India

Contacts

Public ContactNeha Mookim

Kasturba medical college, MANIPAL

ncskumar2005@yahoo.co.in8861196174

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026