GynecomastiaNCT07257445
Modularities of Management of Severe Grades of Gynecomastia.
A study testing Group A: circumerolar skin excision, Group B: elliptical skin excision with pedicled flap +_ lateral roll excision. and Group C: elliptical skin excision with free nipple areola complex +_ lateral roll excision. in people with Gynecomastia, run by Assiut University.
Trial summary
Gynecomastia is defined as a benign enlargement of the mammary glands, commonly diffused among men. The prevalence of gynecomastia ranges from 38 to 64 percent in the male population. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Gynecomastia
- What is being tested?
- Group A: circumerolar skin excision, Group B: elliptical skin excision with pedicled flap +_ lateral roll excision. and Group C: elliptical skin excision with free nipple areola complex +_ lateral roll excision.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Grade IIb, III gynecomastia according to Simon classification.
- Age is between 18 years and 60 years old.
- Stable weight in last 6 months Exclusion Criteria
- 1- Age is below 18 years and above 60 years. 2- Grade I and IIA gynecomastia according to Simon classification. 3- Psychological problems. 4- Non compliant patient. 5- Unstable weight in last 6 months
Who cannot join
None listed.
About this study
Official title: Comparative Study Between Different Surgical Modalities in Management of Severe Grades of Gynecomastia.
Gynecomastia is defined as a benign enlargement of the mammary glands, commonly diffused among men. The prevalence of gynecomastia ranges from 38 to 64 percent in the male population.
Gynecomastia can affect normal self-esteem and sexual identity and often patients feel ashamed of their bodies during normal social activities.
Read more
The surgical management of the high-grade gynecomastia Simon's grade III or Rohrich's grade IV has remained problematic because both liposuction and conventional subcutaneous mastectomy without skin excision have frequently resulted in significant residual skin redundancy, requiring a second operation for skin resection.
Two Classification Systems of Gynecomastia
Rohrich's Classification I, Minimal breast hypertrophy without ptosis; hypertrophy is either primarily glandular or fibrous II, Moderate breast hypertrophy without ptosis; hypertrophy is either primarily glandular or fibrous III, Severe breast hypertrophy with grade I ptosis glandular or fibrous IV, Severe breast hypertrophy with grade II or III ptosis glandular or fibrous Simon's Classification I, Minor breast enlargement without skin redundancy. IIa, Moderate breast enlargement without skin redundancy IIb, Moderate breast enlargement with minor skin redundancy III, Gross breast enlargement with skin redundancy that simulates a pendulous female breast Smoot stated that this approach for high-grade gynecomastia has several disadvantages. There are difficulties in obtaining precertification from third-party payers for a second operation for skin resection. In addition, the adolescent patient is often very anxious during the ensuring 1 year after the original mastectomy when skin excess is quite apparent and awaiting spontaneous shrinkage.
Currently, there are 4 main different approaches for the management of high-grade gynecomastia:
First is simple mastectomy, which is done with free nipple graft accepting the long transverse scar and the grafted appearance of the nipple areola complex. Second is a modification of breast reduction is done with nipple transposition on a single dermal pedicle or vertical bipedicle. A visible chest scar is also present, but the blood supply of the nipple-areola complex is preserved.
Third is ultrasound assisted liposuction is performed first and after several months, accept that several patients will require a second operation to excise the significant residual skin redundancy. Fourth is a single-stage procedure is done in which sub cutaneous mastectomy and circumareolar skin excision are performed. The purse string skin closure limits the scar to the circumareolar area.
Open excision techniques base their principle on a direct view and management of the gland, through several types of surgical accesses according to the surgeon's preference and entity of the defect. The main advantage of open excision is the direct control of the hemostasis and redundant skin control, with the main disadvantage of permanent scars, whose quality cannot be predicted.
Only Gusenoff et al have proposed a classification with corresponding operative treatment options, whose grades taken into account the laxity of the breast skin and the upper abdomen, the location of the inframammary fold IMF, and the lateral fat role.
Minimal excess skin and fat, minimal alteration of NAC, normal IMF, No lateral skin roll: a Minimal excess skin and fat, minimal alteration of NAC, normal IMF, lateral skin roll: b NAC and IMF below, the ideal IMF, lateral chest roll, minimal upper abdominal laxity: c NAC and IMF below the ideal IMF, lateral chest roll, significant upper abdominal laxity: d
Read the detailed description
Cases will be divided into 3 groups according to skin incision:
Group A: circumerolar skin excision Group B: elliptical skin excision with pedicled flap +_ lateral roll excision. Group C: elliptical skin excision with free nipple areola complex +_ lateral roll excision.
Markings
-The preoperative drawings proceed with the patient in standing position.
Group A:
- We normally outline a 30-mm-diameter nipple-areola complex around the existing nipple.
- A second complete circumareolar circle representing the epidermal ring to be deepithelialized, the diameter is adapted in all direction (upper, lower, lateral and medial pole)to achieve the presence of the new NAC in the 4th intercostal space at mid clavicular line .
Group B:
- The sternal notch with the mid sternal line, the inframammary crease line and the mid breast line.
- The new nipple position is located on the 4th intercostal space MCL.
- The mid breast line is marked from the clavicle to the nipple and then continued from the inframammary crease down the lower thoracic wall.
- the new inframammary fold is in the 6th intercostal space about 2-3 cm beneath the ideal NAC position.
- Within this marking the inferior pedicle is designed starting from the NAC apex down to the actual inferior mammary fold. The base of the inferior pedicle should not measure less than 6cm. The excised part marked as an elliptical excision between the actual and ideal inframammary fold with extension to the lateral roll if present.
- The symmetry of the markings, especially the new NAC positions, are checked in front of a mirror.
Group C:
- The sternal notch with the mid sternal line, the inframammary crease line and the mid breast line.
- The new nipple position is located on the 4th intercostal space MCL.
- The mid breast line is marked from the clavicle to the nipple and then continued from the inframammary crease down the lower thoracic wall.
- the ideal inframammary fold is in the 6th intercostal space about 2-3 cm beneath the ideal NAC position.
- The excised part marked as an elliptical excision between the actual and ideal inframammary fold with extension to the lateral roll if present.
- The symmetry of the markings, especially the new NAC positions, are checked in front of a mirror.
Surgical procedure:
- Under general anesthesia, patient is in supine position on the operation room table.
- After marking the incisions and new nipple position, the areola was slightly stretched and marked with a 3 cm cookie cutter.
GROUP A:
- The complete circumareolar ring is deepithelialized.
- An incision is then made from 3 o'clock to 9 o'clock along the inferior border of the deepithelialized ring.
- Subcutaneous glandular excision is completed through that incision.
- a closed suction drain is then placed.
- A 3-0 polypropylene intradermal circumareolar purse string suture is used for skin closure.
- Few interrupted 5-0 absorbable sutures are also used to adjust skin edges at the purse string closure.
- An elastic compressive garment is applied intraoperatively and is worn for 6 weeks.
GROUP B:
- Following marking, epithelialization of the inferior pedicle flap is performed. The excisable tissue is then resected, and the pedicle is carefully dissected down to the pectoral fascia.
- Flap thinning is carried out cautiously, preserving the dermis and a thin layer of subcutaneous tissue to maintain vascularity. A subcutaneous tunnel is subsequently created towards the new NAC site by excising the intervening adipose tissue, allowing for proper transposition of the pedicle.
- After preparation of the tunnel, the inferior pedicle is transposed into the new nipple-areola complex (NAC) site. The pedicle is secured in place with interrupted non-absorbable sutures to prevent displacement and to maintain adequate projection.
- The NAC is then inset into the newly created pocket, ensuring symmetry and central positioning. Excess skin and redundant tissue are trimmed as required to optimize chest contour.
- The wound is closed in layers using deep absorbable sutures for support, followed by a fine subcuticular closure to achieve minimal scarring. Small suction drains may be inserted if necessary to reduce the risk of seroma or hematoma formation.
- Finally, a light compressive dressing is applied to maintain flap stability and reduce postoperative edema
GROUP C:
- After marking, the nipple areola complex will be taken as a full thickness graft
- The excisable part will be excised and restitched by 2-0 vicryl subcutaneously and 3\0 vicryl subcuticular sutures.
- the recipient site of the NAC is deepithelized and the graft will be insit with tie-over for 1 week and the drain inserted for 4-7 days
Postoperative Care
- A change of dressing is carried out after 48 hours.
- Skin stitches are usually absorbed within 3 weeks. Postoperatively.
- Patients are instructed to lie semi-sitting.
Post-operative data:
Breast measurements: the same measurements that were taken preoperatively. patient satisfaction level: which is measured using a questionnaire that have scored through points: completely dissatisfied, slightly dissatisfied, poorly satisfied, fairly satisfied, completely satisfied. aesthetic outcome, nipple sensation , nipple color ,scar satisfaction and muscular contour.
Nipple assessment : colour ,sensitivity and vascularity Scar assessment by VANCOUVER SCAR SCALE 6 months postoperative complication: early such as wound dehiscence, ischemia, hematoma and seroma. Late complications such as nipple pigmentation, nipple sensation, scar, aesthetic outcome.
Photographic Documentation: At the same positions taken preoperatively.
- Conditions
- Gynecomastia
- Being tested
- Group A: circumerolar skin excision, Group B: elliptical skin excision with pedicled flap +_ lateral roll excision., Group C: elliptical skin excision with free nipple areola complex +_ lateral roll excision.
- Keywords
- Severe Gynecomastia, Management of gynecomastia
- Medical subject headings
- Gynecomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: circumerolar skin excisionProcedure or surgery
Surgical procedure:
- Under general anesthesia, patient is in supine position on the operation room table.
- After marking the incisions and new nipple position, the areola was slightly stretched and marked with a 3 cm cookie cutter.
GROUP A:
- The complete circumareolar ring is deepithelialized.
- An incision is then made from 3 o'clock to 9 o'clock along the inferior border of the deepithelialized ring.
- Subcutaneous glandular excision is completed through that incision.
- a closed suction drain is then placed.
- A 3-0 polypropylene intradermal circumareolar purse string suture is used for skin closure.
- Few interrupted 5-0 absorbable sutures are also used to adjust skin edges at the purse string closure.
- An elastic compressive garment is applied intraoperatively and is worn for 6 weeks.
Group B: elliptical skin excision with pedicled flap +_ lateral roll excision.Procedure or surgery
GROUP B:
- Following marking, epithelialization of the inferior pedicle flap is performed. The excisable tissue is then resected, and the pedicle is carefully dissected down to the pectoral fascia.
- Flap thinning is carried out cautiously, preserving the dermis and a thin layer of subcutaneous tissue to maintain vascularity. A subcutaneous tunnel is subsequently created towards the new NAC site by excising the intervening adipose tissue, allowing for proper transposition of the pedicle.
- After preparation of the tunnel, the inferior pedicle is transposed into the new nipple-areola complex (NAC) site. The pedicle is secured in place with interrupted non-absorbable sutures to prevent displacement and to maintain adequate projection.
- The NAC is then inset into the newly created pocket, ensuring symmetry and central positioning. Excess skin and redundant tissue are trimmed as required to optimize chest contour.
- The wound is closed in layers using deep absorbable sutures for support
Group C: elliptical skin excision with free nipple areola complex +_ lateral roll excision.Procedure or surgery
GROUP C:
- After marking, the nipple areola complex will be taken as a full thickness graft
- The excisable part will be excised and restitched by 2\0 vicryl subcutaneously and 3\0 vicryl subcuticular sutures.
- the recipient site of the NAC is deepithelized and the graft will be insit with tie-over for 1 week and the drain inserted for 4-7 days
| Study group | Role | What they receive |
|---|---|---|
| Group A: circumerolar skin excision | Experimental | Group A:
1. We normally outline a 30-mm-diameter nipple-areola complex around the existing nipple.
2. A second complete circumareolar circle representing the epidermal ring to be deepithelialized, the diameter is adapted in all direction (upper, lower, lateral and medial pole)to achieve the presence of the new NAC in the 4th intercostal space at mid clavicular line .
Surgical procedure:
* Under general anesthesia, patient is in supine position on the operation room table.
* After marking the incisions and new nipple position, the areola was slightly stretched and marked with a 3 cm cookie cutter.
* The complete circumareolar ring is deepithelialized.
* An incision is then made from 3 o'clock to 9 o'clock along the inferior border of the deepithelialized ring.
* Subcutaneous glandular excision is completed through that incision.
* a closed suction drain is then placed.
* A 3-0 polypropylene intradermal circumareolar purse string suture is used for skin closure.
* Fe Receives: Procedure: Group A: circumerolar skin excision |
| Group B: elliptical skin excision with pedicled flap +/- lateral roll excision. | Experimental | Group B:
1. The sternal notch with the mid sternal line, the inframammary crease line and the mid breast line.
2. The new nipple position is located on the 4th intercostal space MCL.
3. The mid breast line is marked from the clavicle to the nipple and then continued from the inframammary crease down the lower thoracic wall.
4. the new inframammary fold is in the 6th intercostal space about 2-3 cm beneath the ideal NAC position.
5. Within this marking the inferior pedicle is designed starting from the NAC apex down to the actual inferior mammary fold. The base of the inferior pedicle should not measure less than 6cm.
The excised part marked as an elliptical excision between the actual and ideal inframammary fold with extension to the lateral roll if present.
6. The symmetry of the markings, especially the new NAC positions, are checked in front of a mirror. Receives: Procedure: Group B: elliptical skin excision with pedicled flap +_ lateral roll excision. |
| Group C: elliptical skin excision with free nipple areola complex +/_ lateral roll excision. | Experimental | Group C:
1. The sternal notch with the mid sternal line, the inframammary crease line and the mid breast line.
2. The new nipple position is located on the 4th intercostal space MCL.
3. The mid breast line is marked from the clavicle to the nipple and then continued from the inframammary crease down the lower thoracic wall.
4. the ideal inframammary fold is in the 6th intercostal space about 2-3 cm beneath the ideal NAC position.
5. The excised part marked as an elliptical excision between the actual and ideal inframammary fold with extension to the lateral roll if present.
6. The symmetry of the markings, especially the new NAC positions, are checked in front of a mirror.
* After marking, the nipple areola complex will be taken as a full thickness graft
* The excisable part will be excised and restitched by 2\0 vicryl subcutaneously and 3\0 vicryl subcuticular sutures.
* the recipient site of the NAC is deepithelized and the graft will be insit with tie-over for 1 week. Receives: Procedure: Group C: elliptical skin excision with free nipple areola complex +_ lateral roll excision. |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients satisfaction score after operation
using satisfaction score
1 completely dissatisfied, 2 slightly dissatisfied, 3 poorly satisfied, 4 fairly satisfied,5 completely satisfied.
Measured: Six month.
Secondary outcomes (1)
VANCOUVER SCAR SCALE
(1) height and pliability; and (2) height, pliability, and vascularity. Of note, these combinations did not include the pigmentation sub-score, since pigmentation is scored on a nominal rather than an ordinal scale; i.e., hyperpigmentation (2 points) is not necessarily more severe than hypopigmentation (1 point).
Measured: 6 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GynecomastiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohamed Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257445
- Sponsor's protocol ID
- Severe grades of Gynecomastia
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Different Surgical Modalities in Management of Severe Grades of Gynecomastia.
- ClinicalTrials.gov ID
- NCT07257445
- Acronym / sponsor ID
- Severe grades of Gynecomastia
- Conditions
- Gynecomastia
- Keywords
- Severe Gynecomastia, Management of gynecomastia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gynecomastia is defined as a benign enlargement of the mammary glands, commonly diffused among men. The prevalence of gynecomastia ranges from 38 to 64 percent in the male population.
Gynecomastia can affect normal self-esteem and sexual identity and often patients feel ashamed of their bodies during normal social activities.
The surgical management of the high-grade gynecomastia Simon's grade III or Rohrich's grade IV has remained problematic because both liposuction and conventional subcutaneous mastectomy without skin excision have frequently resulted in significant residual skin redundancy, requiring a second operation for skin resection.
Two Classification Systems of Gynecomastia
Rohrich's Classification I, Minimal breast hypertrophy without ptosis; hypertrophy is either primarily glandular or fibrous II, Moderate breast hypertrophy without ptosis; hypertrophy is either primarily glandular or fibrous III, Severe breast hypertrophy with grade I ptosis glandular or fibrous IV, Severe breast hypertrophy with grade II or III ptosis glandular or fibrous Simon's Classification I, Minor breast enlargement without skin redundancy. IIa, Moderate breast enlargement without skin redundancy IIb, Moderate breast enlargement with minor skin redundancy III, Gross breast enlargement with skin redundancy that simulates a pendulous female breast Smoot stated that this approach for high-grade gynecomastia has several disadvantages. There are difficulties in obtaining precertification from third-party payers for a second operation for skin resection. In addition, the adolescent patient is often very anxious during the ensuring 1 year after the original mastectomy when skin excess is quite apparent and awaiting spontaneous shrinkage.
Currently, there are 4 main different approaches for the management of high-grade gynecomastia:
First is simple mastectomy, which is done with free nipple graft accepting the long transverse scar and the grafted appearance of the nipple areola complex. Second is a modification of breast reduction is done with nipple transposition on a single dermal pedicle or vertical bipedicle. A visible chest scar is also present, but the blood supply of the nipple-areola complex is preserved.
Third is ultrasound assisted liposuction is performed first and after several months, accept that several patients will require a second operation to excise the significant residual skin redundancy. Fourth is a single-stage procedure is done in which sub cutaneous mastectomy and circumareolar skin excision are performed. The purse string skin closure limits the scar to the circumareolar area.
Open excision techniques base their principle on a direct view and management of the gland, through several types of surgical accesses according to the surgeon's preference and entity of the defect. The main advantage of open excision is the direct control of the hemostasis and redundant skin control, with the main disadvantage of permanent scars, whose quality cannot be predicted.
Only Gusenoff et al have proposed a classification with corresponding operative treatment options, whose grades taken into account the laxity of the breast skin and the upper abdomen, the location of the inframammary fold IMF, and the lateral fat role.
Minimal excess skin and fat, minimal alteration of NAC, normal IMF, No lateral skin roll: a Minimal excess skin and fat, minimal alteration of NAC, normal IMF, lateral skin roll: b NAC and IMF below, the ideal IMF, lateral chest roll, minimal upper abdominal laxity: c NAC and IMF below the ideal IMF, lateral chest roll, significant upper abdominal laxity: d
Detailed description
Cases will be divided into 3 groups according to skin incision:
Group A: circumerolar skin excision Group B: elliptical skin excision with pedicled flap +_ lateral roll excision. Group C: elliptical skin excision with free nipple areola complex +_ lateral roll excision.
Markings
-The preoperative drawings proceed with the patient in standing position.
Group A:
- We normally outline a 30-mm-diameter nipple-areola complex around the existing nipple.
- A second complete circumareolar circle representing the epidermal ring to be deepithelialized, the diameter is adapted in all direction (upper, lower, lateral and medial pole)to achieve the presence of the new NAC in the 4th intercostal space at mid clavicular line .
Group B:
- The sternal notch with the mid sternal line, the inframammary crease line and the mid breast line.
- The new nipple position is located on the 4th intercostal space MCL.
- The mid breast line is marked from the clavicle to the nipple and then continued from the inframammary crease down the lower thoracic wall.
- the new inframammary fold is in the 6th intercostal space about 2-3 cm beneath the ideal NAC position.
- Within this marking the inferior pedicle is designed starting from the NAC apex down to the actual inferior mammary fold. The base of the inferior pedicle should not measure less than 6cm. The excised part marked as an elliptical excision between the actual and ideal inframammary fold with extension to the lateral roll if present.
- The symmetry of the markings, especially the new NAC positions, are checked in front of a mirror.
Group C:
- The sternal notch with the mid sternal line, the inframammary crease line and the mid breast line.
- The new nipple position is located on the 4th intercostal space MCL.
- The mid breast line is marked from the clavicle to the nipple and then continued from the inframammary crease down the lower thoracic wall.
- the ideal inframammary fold is in the 6th intercostal space about 2-3 cm beneath the ideal NAC position.
- The excised part marked as an elliptical excision between the actual and ideal inframammary fold with extension to the lateral roll if present.
- The symmetry of the markings, especially the new NAC positions, are checked in front of a mirror.
Surgical procedure:
- Under general anesthesia, patient is in supine position on the operation room table.
- After marking the incisions and new nipple position, the areola was slightly stretched and marked with a 3 cm cookie cutter.
GROUP A:
- The complete circumareolar ring is deepithelialized.
- An incision is then made from 3 o'clock to 9 o'clock along the inferior border of the deepithelialized ring.
- Subcutaneous glandular excision is completed through that incision.
- a closed suction drain is then placed.
- A 3-0 polypropylene intradermal circumareolar purse string suture is used for skin closure.
- Few interrupted 5-0 absorbable sutures are also used to adjust skin edges at the purse string closure.
- An elastic compressive garment is applied intraoperatively and is worn for 6 weeks.
GROUP B:
- Following marking, epithelialization of the inferior pedicle flap is performed. The excisable tissue is then resected, and the pedicle is carefully dissected down to the pectoral fascia.
- Flap thinning is carried out cautiously, preserving the dermis and a thin layer of subcutaneous tissue to maintain vascularity. A subcutaneous tunnel is subsequently created towards the new NAC site by excising the intervening adipose tissue, allowing for proper transposition of the pedicle.
- After preparation of the tunnel, the inferior pedicle is transposed into the new nipple-areola complex (NAC) site. The pedicle is secured in place with interrupted non-absorbable sutures to prevent displacement and to maintain adequate projection.
- The NAC is then inset into the newly created pocket, ensuring symmetry and central positioning. Excess skin and redundant tissue are trimmed as required to optimize chest contour.
- The wound is closed in layers using deep absorbable sutures for support, followed by a fine subcuticular closure to achieve minimal scarring. Small suction drains may be inserted if necessary to reduce the risk of seroma or hematoma formation.
- Finally, a light compressive dressing is applied to maintain flap stability and reduce postoperative edema
GROUP C:
- After marking, the nipple areola complex will be taken as a full thickness graft
- The excisable part will be excised and restitched by 2-0 vicryl subcutaneously and 3\0 vicryl subcuticular sutures.
- the recipient site of the NAC is deepithelized and the graft will be insit with tie-over for 1 week and the drain inserted for 4-7 days
Postoperative Care
- A change of dressing is carried out after 48 hours.
- Skin stitches are usually absorbed within 3 weeks. Postoperatively.
- Patients are instructed to lie semi-sitting.
Post-operative data:
Breast measurements: the same measurements that were taken preoperatively. patient satisfaction level: which is measured using a questionnaire that have scored through points: completely dissatisfied, slightly dissatisfied, poorly satisfied, fairly satisfied, completely satisfied. aesthetic outcome, nipple sensation , nipple color ,scar satisfaction and muscular contour.
Nipple assessment : colour ,sensitivity and vascularity Scar assessment by VANCOUVER SCAR SCALE 6 months postoperative complication: early such as wound dehiscence, ischemia, hematoma and seroma. Late complications such as nipple pigmentation, nipple sensation, scar, aesthetic outcome.
Photographic Documentation: At the same positions taken preoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: circumerolar skin excision | Experimental | Procedure: Group A: circumerolar skin excisionGroup A: 1. We normally outline a 30-mm-diameter nipple-areola complex around the existing nipple. 2. A second complete circumareolar circle representing the epidermal ring to be deepithelialized, the diameter is adapted in all direction (upper, lower, lateral and medial pole)to achieve the presence of the new NAC in the 4th intercostal space at mid clavicular line . Surgical procedure: * Under general anesthesia, patient is in supine position on the operation room table. * After marking the incisions and new nipple position, the areola was slightly stretched and marked with a 3 cm cookie cutter. * The complete circumareolar ring is deepithelialized. * An incision is then made from 3 o'clock to 9 o'clock along the inferior border of the deepithelialized ring. * Subcutaneous glandular excision is completed through that incision. * a closed suction drain is then placed. * A 3-0 polypropylene intradermal circumareolar purse string suture is used for skin closure. * Fe |
| Group B: elliptical skin excision with pedicled flap +/- lateral roll excision. | Experimental | Procedure: Group B: elliptical skin excision with pedicled flap +_ lateral roll excision.Group B: 1. The sternal notch with the mid sternal line, the inframammary crease line and the mid breast line. 2. The new nipple position is located on the 4th intercostal space MCL. 3. The mid breast line is marked from the clavicle to the nipple and then continued from the inframammary crease down the lower thoracic wall. 4. the new inframammary fold is in the 6th intercostal space about 2-3 cm beneath the ideal NAC position. 5. Within this marking the inferior pedicle is designed starting from the NAC apex down to the actual inferior mammary fold. The base of the inferior pedicle should not measure less than 6cm. The excised part marked as an elliptical excision between the actual and ideal inframammary fold with extension to the lateral roll if present. 6. The symmetry of the markings, especially the new NAC positions, are checked in front of a mirror. |
| Group C: elliptical skin excision with free nipple areola complex +/_ lateral roll excision. | Experimental | Procedure: Group C: elliptical skin excision with free nipple areola complex +_ lateral roll excision.Group C: 1. The sternal notch with the mid sternal line, the inframammary crease line and the mid breast line. 2. The new nipple position is located on the 4th intercostal space MCL. 3. The mid breast line is marked from the clavicle to the nipple and then continued from the inframammary crease down the lower thoracic wall. 4. the ideal inframammary fold is in the 6th intercostal space about 2-3 cm beneath the ideal NAC position. 5. The excised part marked as an elliptical excision between the actual and ideal inframammary fold with extension to the lateral roll if present. 6. The symmetry of the markings, especially the new NAC positions, are checked in front of a mirror. * After marking, the nipple areola complex will be taken as a full thickness graft * The excisable part will be excised and restitched by 2\0 vicryl subcutaneously and 3\0 vicryl subcuticular sutures. * the recipient site of the NAC is deepithelized and the graft will be insit with tie-over for 1 week. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Grade IIb, III gynecomastia according to Simon classification.
- Age is between 18 years and 60 years old.
- Stable weight in last 6 months Exclusion Criteria
- 1- Age is below 18 years and above 60 years. 2- Grade I and IIA gynecomastia according to Simon classification. 3- Psychological problems. 4- Non compliant patient. 5- Unstable weight in last 6 months
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A: circumerolar skin excisionSurgical procedure: * Under general anesthesia, patient is in supine position on the operation room table. * After marking the incisions and new nipple position, the areola was slightly stretched and marked with a 3 cm cookie cutter. GROUP A: * The complete circumareolar ring is deepithelialized. * An incision is then made from 3 o'clock to 9 o'clock along the inferior border of the deepithelialized ring. * Subcutaneous glandular excision is completed through that incision. * a closed suction drain is then placed. * A 3-0 polypropylene intradermal circumareolar purse string suture is used for skin closure. * Few interrupted 5-0 absorbable sutures are also used to adjust skin edges at the purse string closure. * An elastic compressive garment is applied intraoperatively and is worn for 6 weeks. | Procedure or surgery | Group A: circumerolar skin excision |
| Group B: elliptical skin excision with pedicled flap +_ lateral roll excision.GROUP B: * Following marking, epithelialization of the inferior pedicle flap is performed. The excisable tissue is then resected, and the pedicle is carefully dissected down to the pectoral fascia. * Flap thinning is carried out cautiously, preserving the dermis and a thin layer of subcutaneous tissue to maintain vascularity. A subcutaneous tunnel is subsequently created towards the new NAC site by excising the intervening adipose tissue, allowing for proper transposition of the pedicle. * After preparation of the tunnel, the inferior pedicle is transposed into the new nipple-areola complex (NAC) site. The pedicle is secured in place with interrupted non-absorbable sutures to prevent displacement and to maintain adequate projection. * The NAC is then inset into the newly created pocket, ensuring symmetry and central positioning. Excess skin and redundant tissue are trimmed as required to optimize chest contour. * The wound is closed in layers using deep absorbable sutures for support | Procedure or surgery | Group B: elliptical skin excision with pedicled flap +/- lateral roll excision. |
| Group C: elliptical skin excision with free nipple areola complex +_ lateral roll excision.GROUP C: * After marking, the nipple areola complex will be taken as a full thickness graft * The excisable part will be excised and restitched by 2\0 vicryl subcutaneously and 3\0 vicryl subcuticular sutures. * the recipient site of the NAC is deepithelized and the graft will be insit with tie-over for 1 week and the drain inserted for 4-7 days | Procedure or surgery | Group C: elliptical skin excision with free nipple areola complex +/_ lateral roll excision. |
Primary outcome
patients satisfaction score after operation
Time frame: Six month.
using satisfaction score 1 completely dissatisfied, 2 slightly dissatisfied, 3 poorly satisfied, 4 fairly satisfied,5 completely satisfied.
1 secondary outcome
VANCOUVER SCAR SCALE
Time frame: 6 month.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Group A: circumerolar skin excision, Group B: elliptical skin excision with pedicled flap +_ lateral roll excision. and Group C: elliptical skin excision with free nipple areola complex +_ lateral roll excision. in people with Gynecomastia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients satisfaction score after operation (time frame: Six month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.