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Thesis Data Analysis: Comprehensive Report
Title: Outcomes of Dermal Regeneration Template with or without Split-Thickness Skin Grafting in Chronic/Complex Wound
Author: Dr. Gauravkumar Govindbhai Patel (MS General Surgery Candidate)
Institution: B.J. Medical College & Civil Hospital, Ahmedabad
Guide: Dr. Hardik B. Bhatt, Associate Professor, Department of General Surgery
University: Gujarat University, September 2025
1. Study Overview
This is a prospective observational study of 50 patients with chronic/complex wounds managed with either:
- Category 1 – DRT + STG (Dermal Regeneration Template + Split-Thickness Skin Graft): 34 patients (68%)
- Category 2 – DRT alone (without immediate STG): 16 patients (32%)
Patients were followed at 8 time points: Day 3, 5, 7, 15, 30, 45 days (1.5 months), 3 months, and 6 months. Outcomes were assessed using graft uptake (%) and the Manchester Scar Scale (MSS).
2. Patient Demographics (from Masterchart — verified)
| Parameter | Value |
|---|---|
| Total patients | 50 |
| Age range | 14–87 years |
| Mean age | 47.4 years |
| Median age | 45 years |
| Male | 38 (76%) |
| Female | 12 (24%) |
| Dominant age group (30–50 yrs) | 22 patients (44%) |
Commentary: The predominance of middle-aged males is consistent with higher occupational injury risk, diabetic foot disease burden, and peripheral vascular disease in this demographic in India.
3. Comorbidity Profile (from Masterchart — computed)
| Comorbidity | n | % |
|---|---|---|
| Diabetes mellitus | 23 | 46% |
| Hypertension | 21 | 42% |
| Tuberculosis | 9 | 18% |
| Thyroid disorder | 8 | 16% |
| Coronary artery disease | 8 | 16% |
| Surgical history | 8 | 16% |
| Congestive heart failure | 2 | 4% |
| Chronic kidney disease | 1 | 2% |
Commentary: Nearly half the cohort had diabetes — the single most powerful predictor of delayed wound healing. The co-occurrence of DM + HTN (both present in many patients) creates a high-risk environment for wound complications. Tuberculosis at 18% reflects the public hospital patient population.
4. Metabolic & Nutritional Status (from Masterchart — computed)
| Parameter | Mean | Notable Finding |
|---|---|---|
| Haemoglobin | 10.39 g/dL | 24/50 (48%) anaemic (Hb <10) |
| Random Blood Sugar | 188.7 mg/dL | 20/50 (40%) had RBS >200 |
| HbA1c | 7.18% | 21/50 (42%) had HbA1c >7% (poor glycaemic control) |
| Serum Albumin | 3.57 g/dL | 23/50 (46%) hypoalbuminaemic (<3.5 g/dL) |
Critical observation: The coexistence of anaemia (48%), hypoalbuminaemia (46%), and poor glycaemic control (42%) in nearly half the cohort represents a severely compromised wound-healing substrate. All these parameters are known independent predictors of graft failure and wound dehiscence. The fact that the study still achieved >99% mean final graft uptake despite these risk factors is a strong argument for the efficacy of DRT.
5. Wound Characteristics
Etiology
| Etiology | n | % |
|---|---|---|
| Diabetic wound | 13 | 26% |
| Trauma | 9 | 18% |
| Infective | 6 | 12% |
| Venous ulcer | 6 | 12% |
| Peripheral vascular disease (PVD) | 5 | 10% |
| Trophic ulcer | 3 | 6% |
| Burn | 2 | 4% |
| Something bite | 2 | 4% |
| Contracture | 2 | 4% |
| Amputation | 1 | 2% |
| Clean surgical wound | 1 | 2% |
Location
The foot was the most common site (52%), followed by leg (14%), thigh (8%), peri-anal (6%), and hand (6%). This foot-predominant pattern is expected given the high diabetic and PVD burden.
Duration
| Duration | n | % |
|---|---|---|
| <15 days | 7 | 14% |
| 15–31 days | 16 | 32% |
| 1–1.5 months | 9 | 18% |
| 1.5–2 months | 5 | 10% |
| 2–12 months | 10 | 20% |
| >12 months | 3 | 6% |
Over 86% of wounds had been present for more than 2 weeks — most were truly chronic. Three patients had wounds persisting for over a year.
Microbiology
| Culture Result | n | % |
|---|---|---|
| No organism | 30 | 60% |
| Pseudomonas aeruginosa | 9 | 18% |
| Staphylococcus aureus | 5 | 10% |
| E. coli | 4 | 8% |
| Acinetobacter baumannii | 2 | 4% |
Gram-negative predominance (Pseudomonas, E. coli, Acinetobacter) in 30% of patients, with some organisms resistant to all antibiotics — consistent with a tertiary-care chronic wound population.
Exposed Bone/Tendon
- DRT+STG group: 7/34 (20.6%) had exposed structures
- DRT-alone group: 5/16 (31.2%) had exposed structures
- Overall: 12/50 (24%) — a challenging subset
6. Primary Outcome: Graft Uptake
By Treatment Category (from Masterchart & Thesis, Table 7.21)
| Follow-up | DRT alone | DRT+STG | Overall Mean |
|---|---|---|---|
| FU1 (Day 3) | 88.81% | 89.71% | 89.26% |
| FU2 (Day 5) | 89.25% | 92.18% | 90.72% |
| FU3 (Day 7) | 90.38% | 89.53% | 89.95% |
| FU4 (Day 15) | 92.31% | 91.94% | 92.12% |
| FU5 (Day 30) | 95.69% | 94.91% | 95.30% |
| FU6–8 (1.5–6 months) | 99.62% | 98.94% | 99.28% |
Statistical result: Mann–Whitney U test p > 0.05 — no statistically significant difference between the two groups at any follow-up point.
Verified from Masterchart: At 6 months (FU8), mean graft uptake = 99.16%, with 34/50 (68%) achieving 100% uptake and 49/50 (98%) achieving ≥98% uptake.
By Wound Etiology (Table 7.20)
- Infective wounds had the lowest early uptake (83.67% at FU1) but caught up to 99.67% by FU6 — indicating that once infection was controlled, DRT worked just as well.
- Trophic ulcers and PVD started higher (94%, 93.2%) but had slower trajectories in the 3–5 follow-up window.
- All wound types converged above 97% by FU6, with Kruskal-Wallis p <0.05 at FU1 (significant early variability) but p >0.05 by FU6 (no significant difference by late follow-up).
7. Secondary Outcome: Manchester Scar Scale (MSS)
Lower scores = better scar quality. MSS ranges from 5 (best) to 18+ (worst).
By Treatment Category
| Follow-up | DRT+STG Mean | DRT alone Mean | p-value (Mann-Whitney U) |
|---|---|---|---|
| FU1 (Day 3) | 7.59 | 6.81 | 0.0622 (NS) |
| FU3 (Day 7) | 7.18 | 6.88 | — |
| FU5 (Day 30) | 7.0 | 6.06 | 0.0141 (significant) |
| FU7 (3 months) | 6.88 | 6.56 | 0.6284 (NS) |
Key findings:
- DRT-alone group had statistically significantly better scar scores at 30 days (p = 0.0141)
- No patients in the DRT-alone group had scores ≥9 (poor scar) at 3 months, vs. 5 patients in DRT+STG group
- By 6 months, both groups converged; the final mean MSS in both groups was approximately 7
By Etiology
- Best final MSS scores: Contracture (5.5), Amputation (6.0), Trophic ulcer (6.0)
- Worst final MSS scores: Burn (8.0), PVD (7.8), Infective (7.0)
- Kruskal-Wallis: non-significant across all follow-ups (p = 0.06–0.59), meaning etiology did not statistically drive scar differences
By Age
| Age Group | FU1 Mean | FU7 (3 months) Mean | Trend |
|---|---|---|---|
| 0–20 | 7.0 | 8.0 | Worsening |
| 20–30 | 7.6 | 6.4 | Improving steadily |
| 30–50 | 7.26 | 6.74 | Improving |
| 50–70 | 7.14 | 6.57 | Improving |
| >70 | 8.2 | 7.2 | Slowly improving |
The 20–30 and 30–50 age groups showed the best scar trajectory. The youngest (<20) and oldest (>70) had persistently higher scores.
By Sex
Both sexes improved over time. Females showed a slightly faster early decline (better early healing), but by 3 months both were comparable (Female mean 6.83, Male mean 6.76 at FU7).
8. Complications (verified from Masterchart)
| Complication | n | % |
|---|---|---|
| No complication | 40 | 80% |
| Infection | 2 | 4% |
| Seroma | 2 | 4% |
| Discoloration | 2 | 4% |
| Edema | 2 | 4% |
| Hematoma | 1 | 2% |
| Failure to uptake of graft | 1 | 2% |
All complications were minor and managed conservatively. The only significant adverse outcome was 1 case of graft failure (2%), which required repeat grafting. No limb-threatening or life-threatening complications occurred.
Compared to published literature (Alet et al., 2013): Your study outperformed on almost every complication metric — notably seroma (4% vs 13.3%) and graft failure (2% vs 20%).
9. Comparison with Published Literature
| Aspect | This Study | Alet 2013 | Rohrich 2025 | Cervelli 2011 |
|---|---|---|---|---|
| n | 50 | 602 pts (26 studies) | 261 pts | 15 pts |
| Mean graft uptake (final) | 99.16% | ~99.3% | — | — |
| Clinical healing rate | 98% | — | 85.4% (DRT arm) | 93% |
| Graft failure | 2% | 20% | 5.2% (DRT arm) | — |
| Infection | 4% | 6.7% | 4.4% | — |
| Seroma | 4% | 13.3% | — | — |
Your clinical healing rate (98%) exceeds Rohrich et al.'s DRT arm (85.4%), though note the different patient populations (your study had younger patients, median 47 vs 65 years).
10. Strengths and Limitations
Strengths
- Well-structured 8-point follow-up protocol capturing both early and late outcomes
- Use of a validated scar assessment tool (Manchester Scar Scale) at every time point
- Diverse wound etiology covering all major chronic wound types
- Real-world tertiary-care data with high-risk comorbidity burden (DM 46%, anaemia 48%, hypoalbuminaemia 46%)
- Confirmed by independent statistical testing (Kruskal-Wallis, Mann-Whitney U)
Limitations
- Sample size (n=50): Some subgroup analyses (e.g., burn n=2, amputation n=1) are underpowered for meaningful conclusions
- Non-randomized allocation between DRT+STG and DRT-alone groups — clinician decision-making likely introduced selection bias (more severe wounds in the DRT-alone group)
- No standardised wound size documentation for comparison across follow-ups
- No ABI (ankle-brachial index) or TCPO₂ data to quantify ischaemia severity
- Short follow-up for some wound types — 6 months may not capture late recurrence or contracture in diabetic foot wounds
- Missing creatinine values in some patients (e.g., row 22 in masterchart) — minor data completeness issue
11. Conclusions
- Both DRT+STG and DRT alone are effective — final graft uptake exceeded 99% in both groups, with no statistically significant difference between them.
- DRT+STG achieved faster closure and was preferred for complex wounds with exposed bone/tendon.
- DRT alone (staged approach) yielded slightly better scar scores at 30 days (p=0.0141), suggesting that allowing full neodermis formation before grafting may reduce early scar tension.
- Wound etiology influenced early but not final outcomes — even infective wounds with <84% uptake at week 1 reached >99% by 6 months with appropriate debridement and antibiotics.
- Complication rate was low (20%), all minor, with only 1 graft failure (2%) — far better than many published series.
- Age, sex, and most comorbidities did not significantly affect final graft uptake or long-term scar quality, though they influenced the tempo of healing.
This thesis makes a strong case that DRT is a safe, effective, and versatile tool for chronic/complex wound reconstruction across a broad patient demographic in a resource-limited setting.
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