1. Title of the project: Evaluation of soft tissue coverage in lower limb defects at a Tertiary care centre. 

2. Type of Study: Prospective observational study. 

3. Aims & objectives: 

 3.a. To evaluate the different options of soft tissue coverage modalities used for the lower limb defects presenting to the Department of plastic surgery. 

 3.b. To evaluate their complications and outcomes. 

 3.c. To assess the duration of stay and cost-effectiveness of the different modalities used. 

4. Justification for study: 

 4.a. The study will evaluate the process of decision-making for soft tissue coverage of complex lower limb wounds. 

 4.b. The study will evaluate the process of soft tissue coverage modalities and observe the outcomes given a particular patient profile. 

 4.c. The duration of stay of each modality as well as its cost-effectiveness can be noted to help make better patient-specific decisions. 

5. Departments involved: Department of Plastic and Reconstructive Surgery. Coordinating department: Department of Orthopaedic Surgery, Department of General Surgery, Department of Surgical Oncology. 

6. Study period: August 2023 to March 2025. 

7. Sample size: In order to evaluate the different modalities for soft tissue coverage of for lower limb defects presenting to our department, with a precision of 5% at 95% confidence level, a minimum of 67 patients need to be enrolled. 

8. Materials and methods: 

a) Inclusion and exclusion criteria: Inclusion criteria: All patients presenting to our department with lower limb defects requiring soft tissue coverage, including but not limited to traumatic amputations, degloving injuries, open fractures, infective wounds, and pressure injuries.

Exclusion criteria: Patients with acute thermal burn wounds. Patients defaulting on treatment. Patients not consenting to be part of the study.

b) Statistical methods: Data collected will be presented in the form of tables and charts using Microsoft Excel and analysed with the help of SPSS software for Windows version 17.0. (SPSS, Chicago, Illinois). Continuous variables will be presented as mean + SD, and categorical variables will be presented as absolute numbers and percentage. Data will be checked for normality before statistical analysis. Normally distributed continuous variables will be compared using the unpaired t test, whereas the Mann-Whitney U test will be used for those variables that were not normally distributed. Categorical variables will be analysed using either the chi square test or Fisher’s exact test. P<0.05 is considered statistically significant. Sample size may vary as per the hospital admissions within the study duration. 

c) Tools used: This study does not require the use of any tools or questionnaires. 

9. Detailed description of procedure: All the patients presenting to our department from August 2023 to March 2025, with lower limb defects requiring soft tissue coverage, satisfying the inclusion criteria will be taken as a part of this study. 

9.a. The following information will be noted: 1. Patient demographics – Age, Sex, Comorbidities. 2. Etiology – Primary injury, type of intervention, Status post-intervention. 3. Plastic surgery - primary team or secondary team – Note will be made of the number and types of surgical procedures undergone for the defect prior to this admission/ department takeover. 

9.b. The defects will be evaluated and a note will be made of:

 i. Anatomical Location : Thigh / Knee / Upper 1/3rd of leg / Middle 1/3rd of leg / Lower 1/3rd of leg / Ankle / Foot- Dorsum / Foot- Plantar .

 ii. Characteristics of the Wound:  Size of wound: (in cm) ; structures exposed ; Presence of infection .

 iii. Usage of NPWT (Negative Pressure Wound Therapy) : Procedure of NPWT: It is a vacuum dressing with a negative suction pressure of -100 to – 125mm of Hg applied to the wound. This dressing is kept in situ for a period of 4 to 7days at a time for each cycle to promote healthy granulation over the wound bed. 

9.c. Note whether there was a need for repair of: Vessel , Nerve , Tendon/ muscle , Bone – Modality used .

9.d. The type of primary reconstructive procedure undertaken will be noted: Split Skin Graft ; Local Tissue Transfer/ Flaps – Types ; Free Tissue Transfer/ Flaps – Types ; Dermal Template ; Amputation .

9.e. Evaluation Of Complications: Eg. Procedure Complication SSG Graft loss/ infection ;Local Flap Marginal necrosis/ infection ;Free Flap Necrosis/ Failure/ infection; Dermal Template No Integration; Amputation Stump Necrosis/ hematoma/ infection .

9.f. The type of Secondary reconstructive procedure undertaken will be noted: Split Skin Graft ,Local flaps – types ,Free tissue transfer – types ,Amputation .

9.g. Total number of surgical interventions. 

9.h. Total number of days of hospital stay. 

9.i. Total cost of treatment. 

10. Outcome measures:

  Skin Graft –  Complete graft uptake (>90%) , Partial graft loss (<50% loss) , Complete graft loss (>50% loss).

  Flap viability – Flap viable , Partial flap loss: Critical area loss Non critical area loss , Complete flap loss.

  Duration of stay in the hospital (in days). Number of surgeries performed. Cost of treatment .

11. Potential risks and benefits: The risk for the study is minimal as only health information, details of surgical procedures conducted, serial clinical evaluation and postoperative reviews are involved in the study.  By understanding the pattern of lower limb wounds and the necessary surgical procedures conducted on them and their outcome will help to set up a improve and standardised protocol for the management of lower limb wounds in the future, and help refine outcomes. 

12. Ethical considerations and methods to address issues: IEC clearance. Patient and party will be given a patient information sheet followed by a written consent form in a language best understood by them. 

13. Budget (give details) and proposed funding source: No additional budget required.